Establishment Inspection Report El: 3005364771 Foundation Care LLC E1 Start/E1 End: 03/ 1 1~19/2013 Earth City, MO 63045-1213 TABLE OF CONTENTS Summary .. 1 Administrative Data .. 3 History .. 4 Interstate Commerce/ Jurisdiction .. 4 Individual Responsibility and Persons Interviewed .. 5 Manufacturing/Design Operations .. 6 Manufacturing Codes .. [2 Complaints .. 12 Recall Procedures .. 12 Objectionable Conditions and Management's Response .. 12 Refusals .. 24 General Discussion with Management .. 25 Samples Collected .. 27 Exhibits Collected .. 27 Attachments .. 29 SUMMARY This was a directed inSpection conducted to evaluate sterile assurance of sterile drug products under FACTS Assignment no. 1495040 and CDER 2/6/2013 assignment. The inspection was conducted per Compliance Program 7356.002, Drug Manufacturing Inspections. This was not a comprehensive inspection. The previous inspection of 8/9-27/2007 was the initial inspection of this ?rm. It was conducted at the request of Center for Drug Evaluation and Reporting (CDER) Division of New Drugs and Labeling Compliance (HFD-317). The inspection was in follow?up to a consumer complaint of an adverse event associated with the use of Colistimethate (premixed for inhalation via a nebulizer) by a Cystic Fibrosis (CF) patient supplied by Foundation Care LLC (Foundation Care). At the conclusion of the 8/9-27/2007 inspection, a nine item FDA 483, Inspectional Observations, was issued and included: no discrepancy report or investigation was generated when a ?Not Sterile? test result was received for Colistimethate. Sterility and endotoxin tests are not conducted on of compounded product per their procedure and potency of the active ingredient is not lof30 Establishment Inspection Report El: 3005364771 Foundation Care LLC El Start/El End: 03/ 1 1-19/2013 Earth City, MO 63045-1213 routinely tested for Colistimethate. The only potency test conducted for Colistimethate was with the stability study in September 2005. The stability study for Colistimethate was inadequate. The Clean Room was not in operation during the ?rst two days of the inspection due to the installation of a new air conditioner in the Cleanroom. Operations started back on 08/11/2007 without requali?cation of the air handling unit. Surface and airborne microorganism samples were not collected between 11/17/06 and 08/11/07 as required by their procedure. The temperature of the incubator is not documented during the incubation period of environmental samples as required by procedures. Not all surfaces in the Cleanroom are smooth surfaces for cleaning: there is tile on the ?oor, a stereo with speakers on a cart and multiple plastic bins used to hold supplies. Two Pharmacy Techs had been assisting with operations in the Cleanroom and neither had completed their aseptic training. Some verbal observations included: the shipping procedure and study are inadequate. No documentation was provided to show respules used in the compounding process for Colistimethate are sterile. Management was warned of their responsibilities under the Act. Management stated they would respond in writing within a week. The ?nal inspection classi?ed was VAI. Corrective actions to the previous FDA 483 were not covered during the current inspection. Foundation Care LLC has been in business since March 2004. The ?rm continues to supply sterile drug products to Cystic Fibrosis (CF) patients. Some of the products they supply are sterile Tobramycin, Colistimethate, and Hypertonic Saline in ampules for inhalation. A seven item FDA 483 was issued at the conclusion of the current inspection and included multiple examples of procedures not established or followed to prevent microbiological contamination and include the following: inadequate media ?ll; environmental personnel monitoring are not performed daily; cleaning in the Cleanroom (Class 100) area was inadequate; the ?rm does not have any documentation of a smoke study to demonstrate the air ?ow in the Cleanroom; the frequency or intervals to change gloves has not been de?ned; procedure for hand washing were not followed; gowning for sterile operations found exposed skin around the face neck and not all the gowning supplied are labeled as sterile. Potency is not conducted on a routine basis for several products and sterility endotoxin test for Hypertonic Saline was last performed in June 2012. The ?rm does not track components used in the process such as TPN and ampules. Glassware used in the cleanroom for waste cleaning is only cleaned and stored in an open area above the hand wash sink. One disinfectant used in the cleanroom is not labeled as sterile and no disinfectant effectiveness studies have been conducted to show the disinfectants reduce bioburden on the different surfaces in the Cleanroom. Management only mentioned correction of two points of the FDA 483. No samples were collected. The ?rm was reminded of their responsibilities under the Act. Refusals were encountered during the inspection. The refused to provide us with photocopies of documents then said he was wrong and allowed us photocopies. He also refused to allow us to take pictures in the Cleanroom or to allow us to take paper into the room. See Refusal section of this repOrt for additional refusal related issues. 2of30 Establishment Inspection Report Flil: 300536477] Foundation Cure LLC EI Start/151 End: 03/11-19/2013 Earth City, MO 63045-1213 ADMINISTRATIVE DATA Inspected tirm: Foundation Care LLC Location: Phone: FAX: Mailing address: Dates ofinspection: 3/11/2013, 3/l2/2013. 3/13/2013. 3/l4/2013e 3/18/2013, 3/19/20l3 Days in the facility: 6 Participants: Shirley J. Berryman, Investigator Michele l'en'y Williams. Investigator Anthony Bucks. Investigator Michele Peny--Williams, Investigator, was present 3/1 144/2013. Steven S. Smith, Inspector with the Missouri Board of Pharmacy accompanied us on the inspection all days except for 3/19/2013. Anthony Bucks, Investigator, was present on I (Shirley J. Ben'yman, Investigator) was present the entire inspection. There were three. FDA 482, Notice issued during the inspection and all were issued to Daniel Blakeley. CEO and Pharmacist-in-Charge. Mr. Blakeley is the most responsible individual and should receive and official correspondence at the firm address. On 3/11/2013, investigator Perry-Williams and I presented our credentials and issued the initial FDA 482. On 3/12/2013 we issued another FDA 482 when we inspected the firm's warehouse located near the facility at 4090 Wedgewzy Court, Earth City, MO 63045. On 3/18/2013, when Investigator Bucks joined the inspection, Investigator Bucks and I presented our credentials and issued the third FDA 482. Daniel Blakeley. CEO. Pharmacist-imChatge (Io-owner; Michael A. Schultz, Quality Control (In-owner: Lindsay Manager Marketing Regulatory and Regulatory 3: Documentation Specialist were present at the close-out meeting along with Investigators Bucks and me. The Original FDA 483. Inspections] Observations was issued to Mr. Blakeley on 3/19/2013. Firm management informed us they have documentation to support the observation. The FDA 4133. Amendment 1 Wasthen issued to remove the item. See General Discussion with Management for further discussion. The Original FDA 483 was collected from the firm. Investigator Perry-Williams wrote Recall Procedure section, FDA 483 Items l.a-l.i; 3, 4 and 6 and co-authored the narrative for the FDA 48] sections. The rest sections were written by me, Investigator Berryman 302'30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC El Start/El End: 03/ 1 1-19/2013 Earth City, MO 63045-1213 HISTORY Foundation Care LLC started in business in March of 2004. The ?rm was incorporated in the State of Missouri on March 1, 2004. Mr. Daniel P. Blakeley, is Managing Partner, CEO and Pharmacist-In-Charge and Mr. Michael A. Schultz, is also a Managing Partner, Quality Control and the CFO. Mr. Blakeley and Mr. Schultz are co-owners of the business. Mr. Blakeley is the most responsible individual at the ?rm and should receive all correspondence. The pharmacy provides prescriptions primarily to Cystic Fibrosis patients. Mr. Blakeley stated they are licensed and ship to 50 states. They have employees and their business hours are 8:00 am. to 6:00 pm. Monday through Friday. The last Missouri Board of Pharmacy inspection at Foundation Care LLC was 8/16/2012 and reported no observations. The ?rm is not registered with the Food and Drug Administration as a drug establishment. The ?rm has had a recall last year. See heading ?Recall Procedure? for additional information. INTERSTATE JURISDICTION Mr. Blakeley stated approximately of ?nished products are distributed outside the State of Missouri. According to Mr. Blakeley, the pharmacy is licensed in 50 states. The ?rm continues to produce ampules of drug products from sterile drug products and components for Cystic Fibrosis patients. According to Mr. Blakeley, the products are Tobramycin, Colistimethate and Hypertonic Saline. A list of all products is attached as Exhibit 1 and lists the following information for the products: 0 Tobramycin 150mg/3m10.45% NaCl; Tobramycin 170mg/3.4m10.45% NaCl 0 Colistimethate 75mg/3m10.225% NaCl; Colistimethate 150mg/4ml 0.225% NaCl 0 Hypertonic Saline 3% 3ml, 4ml 5ml 0 Hypertonic Saline 4% 3ml 4ml 0 Hypertonic Saline 5% 3ml, 4ml 5ml 0 Hypertonic Saline 6% 3ml, 4ml 5ml 0 Hypertonic Saline 8% 3ml, 4ml 5ml 0 Hypertonic Saline 10% 3ml 4of30 (b)(6); (b)(7)(C) (b)(6); (b)(7)(C) (b)(6); (b)(7)(C) (b) (4) (b) (6) (b)(6); (b)(7)(C) (b)(6); (b)(7)(C) (b)(6); (b)(7)(C) Establishment Inspection Report El: 3005364771 Foundation Care LLC El Start/El End: 03/1 1-19/2013 Earth City, MO 63045-1213 MANUFACTURINGIDESIGN OPERATIONS The ?rm is located in a business park. They process primarily antibiotics for Cystic Fibrosis patients along with Hypertonic Saline. A copy of the ?rm?s product list for 2012 was obtained is attached as Exhibit 1. The facility has expanded since the previous inspection and is currently at sq. ft. (the 2007 EIR reports - sq. ft.) The facility includes: Class 100 Cleanroom (ISO-5), Class 10,000 Anteroom (ISO-7), pharmacy where drugs are stored and prescriptions are ?lled, shipping receiving dock, and walk-in cooler freezer. Finished sterile products are stored in the cooler. A facility diagram is attached as Exhibit 3. Compounding of non-sterile products is conducted in a hood in the Pharmacy area. Quality System: The Quality System was covered through the review of procedures and documents. The ?rm reports no complaints since January 2012. The Complaint procedure was reviewed and discussed under the Complaint heading. The ?rm does not routinely conduct stability and no stability failures were noted (see Laboratory Control ystem/ Stability and General Discussion with Management for additional information regarding stability). The firm does have designated areas for quarantine products. Training was covered as far at the media ?lls they conduct as part of the training program. The ?rm has had one recall since January 2012 for Tobramycin. The ?rm determined the positive sterility failure was due to laboratory error. See heading Recall Procedure of the EIR for further discussion. Facilities and Equipment System: The Facilities and Equipment System was covered through visual observation, review of procedures and documents. The facility appeared visually clean. No objections were noted with the pest control system. The last pest control visit was 2/22/2013. There is a at the entry to the Anteroom and a to the Cleanroom. Procedure 12, Positive Pressure Monitoring? (Exhibit 4) requires a A to be logged during compounding activities. Compounding Formula Records reviewed found the Cleanroom Positive Pressure and Clean Room Temperature documented. Procedure Use of Anteroom? (Exhibit 5) states it is for storage of Cleanroom supplies. It is also where employees gown, wash their hands prior to entry to the Cleanroom, clean equipment and sanitize products containers prior to entry into the Cleanroom. Exhibit 6 is a diagram of the Anteroom and Cleanroom. The Cleanroom has a long work bench 0n the back wall and two smaller tables on each side. Table 2 is where products are ?lled. The tables have a lower shelf where non?solid side plastic bins hold supplies and components. An outdoor stereo speaker is located on the lower shelf on Table 1. There are two stools in the room that we observed the operators to use as table tops during the cleaning process. There is a plexiglass-type box opened at the bottom for the exit air. During the previous inspection a FDA 483 item was issued for not having smooth surface on the Cleanroom ?oor (tiled ?ooring). The current inspection found 6of30 Establishment Inspection Report El: 3005364771 Foundation Care LLC E1 Start/El End: 03/ 1 l-19/2013 Earth City, MO 63045-1213 the ?ooring is now a smooth surface. The anteroom has a sink for cleaning and hand washing. The Cleanroom does not have any sink or drains. The ?rm continues have the HEPAs for the Cleanroom quarterly recerti?ed quarterly by Ace Electric Laboratory Systems (Ace), St. Louis, MO. The Cleanroom is classi?ed Class 100, ISO-5 and the Anteroom is classi?ed Class 10,000 or ISO-7. The ?rm has no documentation of a smoke study to verify the air?ow in the Cleanroom since its installation in 2004. Mr. Blakeley stated conducted a smoke study but did not video record it. The ?rm installed a new air conditioning unit in 2007 and no new smoke study was conducted. See FDA 483 Item 1.d. for objection noted. Equipment used in the sterile processed appeared adequate for the intended use. No new equipment was noted since the previous inspection. Cleaning procedures were reviewed. FDA 483 Item 7 describes concerns with the ?rm?s use of disinfectants not labeled as sterile in the Class 100 ISO 5 areas and the lack of disinfectant effectiveness studies to assure disinfectants used are effective at reducing bioburden on the various surfaces in the Cleanroom. Equipment and surfaces in the clean room are cleaned sanitized at the beginning of each product and at the end of each product. See FDA 483 Item 1.3 for additional information. Materials System: The coverage of the Materials System focused on the receipt and handling of raw materials by observation and review of procedures records. We observed the movement of supplies, materials and personnel into the Cleanroom on the ?rst day of the inSpection and again on 3/ 14/2013. Exhibit 4, Use of Anteroom? instructs to gather all supplies onto a cart and remove the outer boxes before entering the anteroom. The carts are not allowed to enter the anteroom as well as no cardboard or loose paper (the batch record is placed in a plastic paper holder which is wiped with IPA prior to entry into the Cleanroom). We observed components and prepackaged supplies sanitized in the pharmacy area and sprayed with Sterile Isopropyl Alcohol in the Anteroom. Components supplies are used on a ?rst in-?rst out basis. Sec FDA 483 Item 7 for issued noted with re-used glass beakers for waste and cleaning. We observed only the surgical gown and gloves to be labeled as sterile. Note the surgical gown does not cover the operator?s legs and operators have exposed skin on the face and neck. In addition, employees are allowed to launder their own scubs they wear underneath the surgical gown. See FDA 483 Item 2 for objections noted with gowning. Mr. Blakeley stated they occasionally get certi?cate of analysis for the sterile gowns. We were shown recent Certi?cate of Product Conformance and Sterility for a large and XL gowns from We reviewed the packaging for the hair covers, shoe covers and dust?type mask and found them not labeled as sterile. See Photos 1 and 2, Exhibit 7 for photographs after ?ll on 3/13/2013. 7of30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC E1 Start/E1 End: 03/ 1 1-19/201 3 Earth City, MO 63045?1213 We noted the use of pre-sterilized deprogenated single-use equipment: tubing, TPN bags for pooling, etc. They do not sterilize any equipment, containers, or closures on site. We did not observe any non-sterile components in the process. Mr. Blakeley stated they do not ship products on since all the sterile products are shipped refrigerated. Production System: We (Investigators Berryman and Perry-Williams) evaluated the Production System. This system was covered through observation, review of procedures related documents and included: observing set-up, ?ll operations and cleaning in the Cleanroom and 3/1 1/2013 and Investigator Perry-Williams observed operations on 3/14/2013. On 3/11/2013 we watched a simulation for about 11/2 hours. The process started in the Pharmacy where the operators collected the Hypertonic Saline and other components. The cart and components are sanitized. We followed the operators to the Anteroom where they gowned and prepared for the sterile till. I informed the operators although this was a simulation they should handle it as if it was actual sterile ?ll as we might not have another opportunity to observe operations. We observed several unacceptable practices during the sterile fill of Hypertonic Saline lot Investigator Perry-Williams observed a portion of the process for Tobramycin lot ?ta150-1303 14? on 3/14/2013. See FDA 483 Items 1.e, 1.f, Lg, 1.h, Li, and 2 for conditions observed. We asked Mr. Blakeley what the products were according to volume produced. He said We requested a list of all sterile products produced in January, March and August for 2012. We were provided with January 2013. After checking with my supervisor we did not review January 2013 and requested January 2012. We selected the following products as a result of the total amount produced in the months: Colistimethate for January 2012 (Exhibit 8), Tobramycin for March 2012 (Exhibit 9) and Colistimethate for August 2012 (Exhibit 10). 1 asked Ms. Wessels about the low volume products produced in August. She said we were missing a page. But we didn?t change to the product for August. We later collected 15 prescriptions for December 2012 (Tobramycin Exhibit 11) at the request of my supervisor. Review of these prescriptions found them to contain the patient name, date of prescription, drug product name and date of the prescription pre-dates the shipment date. Initially we received a list of batches for January, March, August and December 2012. I later informed Mr. Blakeley we need a list of batches for 2012. He said it would take some time to generate it but if we really needed it he would provide it. After I reminded him for the third time he said he hadn?t forgotten. He e-mailed me the list on 3/ 15/2013. 1 was provided with a copy when I returned to the firm on 3/18/2013 which is attached to this report as Exhibit 12. We did not observe any anticipatory products and record review of four batches found the entire lot went out under prescriptions and was accounted for the lots listed below. From the ?2012 Compounded Products? list, we (Investigators Berryman and Perry-Williams) selected one batch from January, March, August and December 2012. We requested the batch record and related prescriptions and con?rmed. The documents also included the Pharmacy Work Order Sof30 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b)(6); (b)(7)(C) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) Establishment Inspection Report FEI: 3005364771 Foundation Care LLC EI Start/El End: 03/11-19/2013 Earth City, MO 63045-1213 MANUFACTURING CODES A lot number is assigned to each batch produced. The lot numbering system has changed since the previous inspection. The For example: C75121228 is COMPLAINTS Mr. Blakeley reports no complaint for 2012 and 2013. A copy of Complaint? procedure was reviewed and a copy is attached as Exhibit 20. All employees are trained on how to handle complaints. Their complaint form includes the person reporting the complaint, summary of the complaint including date received, summary of actions taken to resolve the complaint and signature of supervisor. A written response is to be provided to the complainant within calendar days. Copies of complaints and investigations are to be kept on ?le for . The complaint procedure does not require obtaining the lot number of products. This was not listed on the FDA 483. RECALL PROCEDURES Exhibit 21, is the SOP (Standard Operating Procedure) ?11.1 Recall Procedure Pharmacy Product?. Documentation regarding the recall of Tobramycin Sulfate, lot no. 9150-130305, was reviewed during this establishment inspection. One of their contract testing laboratories, reported a sterility failure on 5/17/12. This product had been compounded on 5/1/12 and dispensed on 5/7 and 5/1 1/12. Their Recall SOP, Recall Strategy for this Recall, and veri?cation that communication was made through e-maii and telephone was reviewed. The ?rm provided information on each of their customers who received this product and documentation to show they had been contacted and information on the quantity of product which had been returned. The firm received product back which was tested by another contract testing lab which was found acceptable. The conclusion of the information conducted as a result of this Recall found the reported failure was due to a laboratory error. The investigation appeared adequate. OBJECTIONABLE CONDITIONS AND RESPONSE Observations listed on form FDA 483 12 0f30 Establishment Inspection Report El: 3005364771 Foundation Care LLC El Start/E1 End: 03/1 1-19/2013 Earth City, MO 63045?1213 OBSERVATION 1 Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. Speci?cally, a. Your media ?ll procedure and documentation, which are used to validate your sterile processing operations, are inadequate. You failed to a perform media ?ll simulation, including documenting the following kinds of information: 1) Average and worst case processing times. 2) Document the different kinds of interventions, along with the average and maximum number of interventions. 3) The maximum number (under worst case Scenario) or personnel in the cleanroom (Class 100 i.e. ISO 5 zone) during dynamic processing operations. b. Your SOP 8B.16 "Environmental Testing for Cleanroom? fails to include instructions on daily monitoring under dynamic conditions (when processing occurs) in your Class 100 (ISO 5 zone) cleanroom as it instructs for environmental monitoring only for equipment and air sample (viable and non-viable monitoring). In addition, this SOP does not include all of the equipment contained in your Class 100 cleanroom to be included in your monitoring program. For example it fails to include and you fail to monitor the following (this is not an inclusive list): 1) One (1) BAXA Pump 2) Two (2) Chairs 3) Fifteen (15) plastic storage bins located on the lower shelf of one of your long tables; 4) Five (5) black plastic vial racks used to hold your ampules which are passed into the heat sealer for ampule sealing operations; 5) Speaker located on the bottom shelf of your short table; 6) Door knobs, walls, and floors. c. You failed to perform daily environmental monitoring (or when processing occurs) of your personnel. Your SOP 3C.4 "Compounding Personnel Training" instructs you to conduct annual personnel monitoring activities only. For example: was last monitored 10/19/2012 and was last monitored 10/18/2012. d. You failed to have a smoke study procedure used to evaluate your cleanroom suite (Class 100) under dynamic conditions and employee stated you have not conducted a smoke study since the room was installed in 2005. 13of30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC El Start/El End: 03/ 1 1-19/2013 Earth City, MO 63045-1213 Additionally, you failed to conduct a smoke study after a new air handling unit was installed in 2007. e. You failed to use appropriate aseptic cleaning practices as you do not always use overlapping cleaning strokes, cleaning from the top to the bottom, from the back to the front and from the inside/outside of your cleaning areas and equipment as observed on 3/ 12/2013. f. Your ?rm has not de?ned a frequency or intervals where gloves must be changed out. Compounding Garb" only states to spray gloves with "Sterile 70% On 3/11/2013 during the ?ll of Hypertonic Saline 4% Lot employee dropped the disinfectant bottle once at the end of processing and once during cleaning. He sprayed the bottle with Sterile IPA (Isopropyl Alcohol), placed it back on the lower shelf, continued to work and did not change his gloves. Neither pharmacist technicians changed their gloves during the process and they only wore one pair of gloves. g. While observing cleaning operations on 3/11/2013 in the anteroom employee left the door between the cleanroom (Class 100) and anteroom (Class 10,000) open at least 3 times for over 5-10 second after cleaning/sanitization of the Clean Room. The door does not automatically close nor is there an airlock between the rooms. h. You failed to follow your SOP 8B.5 "Hand Washing -Sterile Compounding". On 3/11/13 and 3/13/13, your employees and both failed to allow "water to run from ?ngertips toward elbows" during the rinsing of their hands as required by the procedure. i. There is no clock or time instrument in the anteroom to make sure employees preparing for aseptic production scrub their hands for a minimum of 30 seconds in accordance to their procedure 8B.5 "Hand Washing -Sterile Compounding." Reference: 21 CFR 211.113(b) Supporting Evidence and Relevance: 1.a. Documents provided for media ?ll is attached as Exhibit 22 and includes a copy of Test Kit which includes a laminated card that comes with the test kit from The exhibit also includes the Media Fill Testing Log for documentation Mr. Blakeley, Ms. Heyde and :ompleted a media ?ll in October 2012. l4of30 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) Establishment Inspection Report FEI: 3005364771 Foundation Care LLC El Start/E1 End: 03/ 1 1-19/2013 Earth City, MO 63045-1213 quarterly. The Exhibit includes the 7/24/2012 recerti?cation and test data. Test conducted for both the Anteroom and the Cleanroom are: 1.e. Exhibit 28 SOP Anteroom Cleanroom Cleaning Procedures? and Exhibit 29 SOP Cleaning and Maintenance of Cleanroom Equipment? were not followed and or failed to include instructions for a Class 100 area for the following: use overlapping strokes when cleaning; clean from the inside toward the outside of the equipment and work stations and clean from the top toward the bottom of work spaces. In addition, neither SOP SB. 19 nor 8B.20 requires cleaning of the chairs in the Cleanroom. Other related procedures reviewed during the inspection: Exhibit 32 SOP General Aseptic Procedures Used at the Clean Room Workbench?. 1.f. Exhibit 30 SOP Compounding Garb? has not de?ned a frequency or intervals where gloves must be changed out. This SOP only states to spray gloves with ?Sterile 70% During the operations we observed poor aseptic practices being used on 3/11/2013 during the ?ll of Hypertonic Saline 4% Lot 4HS4-130311. Employee dropped the disinfectant bottle once at the end of processing and once during the cleaning process. He sprayed the bottle with Sterile IPA (lsopropyl Alcohol), placed it back on the lower shelf, continues to work and did not change his gloves. Neither pharmacist technicians changed their gloves during the process and they only wore one pair of gloves. Exhibit 32 SOP General Aseptic Procedures Used at the Clean Room Workbench? states under 9. Use sterile 70% on the surface of gloved hands, as necessary. 1.g. Exhibit 5, Copy of SOP Use of Anteroom? explains the route of getting product in the Cleanroom. It also states that of doors and under 6.b. door should only be open for a minimal amount of time. 1.h. and Li. See ?rm?s procedure attached as Exhibit 33 Hand Washing?Sterile Compounding? and Exhibit 31, Compounding Formula Record for Hypertonic Saline 4% lot 4HS4- 130311. SOP 8B.5 was not followed. On 3/11/13 and 3/14/13, your employees and both failed to allow ?water to run from their ?ngertips toward elbows? during the rinsing of their hands as required by the procedure. Additionally, there is no clock or time instrument in the anteroom to make sure employees preparing for aseptic production scrub their hands for a minimum of 30 seconds in accordance to this SOP. Discussion with Management: Regarding 1.a. Mr. Blakeley said this information was provided to us during the inspection. He stated he didn?t know what an intervention was. Investigator Bucks explained and Mr. Blakeley stated they call that manipulations. I said you are performing the media ?ll as part of employee training and not to validate the process. 16 of30 Establishment Inspection Report FBI: 3005364771 Foundation Care LLC E1 Start/E1 End: 03/ 1?19/2013 Earth City, MO 63045?1213 l.b. This item should be conduct daily to show they have a sterile process. Management stated they follow state/laws and exceeding guidelines for pharmacies. Mr. Blakeley agreed he should have a list of what equipment is in the Cleanroom. l.e. Mr. Schultz stated they use soapy water, disinfectant and IPA. So they are wiping down the surfaces three times. He said one of his audits found their method acceptable since they were wiping down the surfaces three times. l.g. Management didn?t seem to think this was an issue with the Cleanroom being at positive pressure and said they won?t get a back ?ow. OBSERVATION 2 Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform. Speci?cally, during processing of vaertonic Saline on 3/11/2013 and Tobramycin on 3/14/2013 both employees and were observed with exposed skin around the neck and face. The operators do not wear the jumpsuit style but Royal Silk Surgical Gown which wraps around, ties on the side and not totally closed in the back. In addition, the bouffant cap, surgical mask, shoe covers they wear are not sterile to protect pharmaceuticals which are preservative free such as Tobramycin, Colistimethate and Hypertonic Saline. The Pharmacist- in-charge stated the scrubs worn underneath the Gown are laundered at home by the employees. Reference: 21 CF 21 l.28(a) Supporting Evidence and Relevance: Exhibit 7 Photo 1 is a front view of Pharmacist Tech preparing to exit the Anteroom and Photo 2 is a back view of Pharmacist Tech preparing to exit the Anteroom. The photOgraphs were taken on 3/13/2013. It is unknown if the employees working in the Cleanroom wear facility dedicated shoes. Exhibit 30 Compounding Garb? Exhibit 31 Compounding Formula Record for Hypertonic Saline 4% lot 4HS4-1303 11 l7of30 Establishment Inspection Report 3005364771 Foundation Care LLC El Start/E1 End: 03/ 1-19/2013 Earth City, MO 63045-1213 Discussion with Management: We observed the pharmacist technician?s gown in the anteroom during the inspection on 3/11/2013 during a ?simulation?. Investigator Perry-Williams observed the process of Tobramycin on 3/14/2013, and 1 took the picture of gowned on 3/13/2013. When we asked to observe ?lling operations in the Cleanroom Mr. Blakeley asked if we had our own scrubs. Investigator Perry-Williams asked Mr. Blakeley if the employees purchase their own scrubs and he stated they did. He also stated employees are required to launder their own scrubs. He said they change into the scrubs at the firm. changes into her scrubs either in the bathroom or in a cubicle, uncontrolled areas. On the ?rst day of the inspection we conducted an inspection of the facility by following the process, from the pharmacy, where components are received, then I asked to go to the Cleanroom to watch filling operations. Mr. Blakeley stated we couldn?t go into this area as we didn?t have our own scrubs and we would disrupt the air ?ow. Eventually he stated we could observe before Operations they would have to do a thorough clean after we were in the Cleanroom and they would have to throw away the product. We contacted our office and obtained white jumpsuit type over cover and he agreed we could wear the jumpsuit over our clothes. They agreed we could watch the process at the end of the day. I stated they should operate as if it was the actual process as it might be our only opportunity to watch the process. The hand wash sink is in the anteroom and the water temperature is controlled by foot pedals for both hot and cold. The pharmacist technicians stated the temperature is difficult to regulate. While washing my hands, I agree it was either very hot or cold. I finished washing my hands and was informed by that I had not washed my hand long enough so I continued to wash my hands. It is the firm?s responsibility to assure we are following their procedures when we go through their process. OBSERVATION 3 Laboratory controls do not include the establishment of scientifically sound and appropriate designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. Speci?cally, a. Potency is not performed on a routine basis. Your procedure 8B.13 Contract Laboratories Sample Testing Frequency states ?Potency testing may be done on a random basis or at the Pharmacist-in-Charge's or Quality Assurance Officer's discretion.? For example: 1) Hypertonic Saline potency was last tested in July 2009. 18 of30 Establishment Inspection Report Foundation Care LLC Earth City, MO 63045-1213 FEI: 3005364771 El Start/El End: 03/11?19/2013 2) Tobramycin potency was last tested in December 2012. 3) Colistimethate was last tested for potency in September 2005. Reference: 21 CFR 21 1.160(b) Supporting Evidence and Relevance: The following are documentation of the last potency test provided: Exhibit 34 Certi?cate of Analysis for Hypertonic Saline 3%/3mL for 7/29/2009 documenting this product was last tested in July 2009. Exhibit 35 COpy of l70mg/3.4ml 0.45 NaCl for 6/21/2012 Exhibit 36 Stability of Colistimethate September 2005 documenting this product was last tested in September 2005. Certi?cate of Analysis for Tobra Exhibit 37 1 3 Contract Laboratories Sample Testing Frequency? procedure states from is tested for lot of sterile compounded product is sent for testing according to USP 797 It also states sample requirements for sterility and fungal.? The values in the Table 2 were manually tabulated from the 2012 Compounded Products Spreadsheet provided by the ?rm (attached as Exhibit 12) and represent approximate values. Table 2 Product 1 Month/year Number Largest Smallest Total Total Units Batches lot lot units for for 2012 (units) (units) Tobramycin January 2012 Tobramycin Tobramycin August 2012 Colistimethate January 2012 [Elistimethate March 2012 Colistimethate August 2012 Hypertonic Saline January 2012 Hypertonic Saline March 2012 lilypertonic Saline August 2012 19 of30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC E1 Start/E1 End: 03/ 1 1-19/2013 Earth City, MO 63045-1213 Discussion with Management: Mr. Schultz stated the Colistimethate is a sophisticated potency test as it is a ?Pro-Drug?. He also stated it was a dollar test. Both Mr. Blakeley and Mr. Schultz indicated FDA had tested for potency and sterility for them on the samples I (Investigator Berryman) collected during the inspection of 2007. Mr. Blakeley stated they exceed the Board of Pharmacy requirements for testing. Mr. Bucks asked Mr. Blakeley how they were making sure they are making their potency speci?cations with . At one point Mr. Schultz stated you count the product you have when you start and count the ?nished product when you are done to see if it is all accounted for. OBSERVATION 4 Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Speci?cally, you do not perform sterility and endotoxin test on a routine basis for Hypertonic Saline which was last tested for sterility in June 2012. Reference: 21 CFR 211.165(b) Supporting Evidence and Relevance: Exhibit 37 Contract Laboratories Sample Testing Frequency? procedure states A is tested for It also states sample from lot of sterile compounded product is sent for testing according to USP 797 requirements for sterility and fungal.? Exhibit 38 Microbiology Report dated 7/28/2009, page 1. In addition, page 2 is Colistimethate Microbiology Report is dated 8/31/2012. Pages 3-7 are 2012 results from for Tobramycin. Exhibit 47 Microbiology Report from for Hypertonic Saline sterility test in June 2012; Endotoxin and Sterility Certi?cate of Analysis from for Tobramycin dated 3/15/2013 and Colistimethate 3/15/2013. 20 of30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC El Start/El End: 03/11?19/2013 Earth City, MO 63045-1213 Discussion with Management: Management provided additional information prior to the conclusion of the inspection included above. OBSERVATION 5 The records for components and drug product containers or closures do not include the supplier's lot number. Speci?cally, a. You did not document the lot number of the TPN bags used in the sterile drug process for the following but not limited to: Tobramycin Lot TA170-120103B, TA170-120327B, TA170-121211A, and Colistimethate Lot C75-120816. b. Ampule lot numbers used in sterile drug products are not documented. Ampules used in the process are received from the sterilization company have a list of lot number on the shipping carton but do not have lot numbers on the individual bags. Reference: 21 CF 21 1.184(a) Supporting Evidence and Relevance: Exhibit 39 Copies of Compounding Formula Records for Tobramycin lot TA170-130312B and ta150-130312A and TA170-130312A. Also, please note the ?rst page of Exhibits 13 16, Compounding Formula Record lists Bag? and Ampules? without recording a lot number. If the manufacturer of the TPN bags or Ampules had a recall it would be dif?cult to identify the Speci?c lot. In addition, it would be dif?cult to conduct an adequate investigation if the ?rm had an issue relating to either the TPN bags or the Ampules. Discussion with Management: Management did not comment on this observation. 21 of30 Establishment Inspection Report El: 3005364771 FOundation Care LLC E1 Start/El End: 03/ 1 1?19/2013 Earth City, MO 63045-1213 OBSERVATION 6 Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. Speci?cally, there is no documented cleaning of the glassware prior to use in the cleanroom. You failed to render glassware re-used in your Cleanroom (Class 100 area) in a sterile condition prior to being introduced into your Cleanroom. This re-used glassware is located on the tables in close proximity to your processing area which includes opened ampules before sealing activities occur. Your SOP 8B.21 ?Washing Glassware for use in the Cleanroom? instructs your employees to rinse the glassware using tap water, wash with liquid detergents, wipe with IPA, etc. After the washing/drying steps this SOP instructs them to hang the glassware ?on rack to dry?. This rack is located in the anteroom (class 10,000) area which does not have documented cleaning of this storage area. We observed this practice on 3/11/2013 during the cleaning process after the sterile ?ll of Hypertonic Saline. Reference: 21 CFR 21 l.67(a) Supporting Evidence and Relevance: Related exhibits: Exhibit 40 SOP Washing Glassware for use in the Cleanroom?. This glassware was observed to be used for cleaning activities along with being placed on the tables where sterile activities occur during the process. This glassware has not been rendered sterile and is used and manipulated during sterile operations. Exhibit 41 Compounding Area Cleaning Log does not provide evidence that this glassware is sterilized and is being introduced to the ?rm?s cleanroom (Class 100). This glassware is also placed on the counter during sterile compounding operations. The log is an example of the current cleaning of the Cleanroom and Anteroom. Daily cleaning is checked off for the room, machines, carts tablets, waste removal, tacky mat removal and ?oors. The month cleaning documents a check mark for walls, ceilings storage units and supplies. It is important to note, the two chairs noted in the Cleanroom on 3/11/2013 are not on the list for cleaning. We observed the chairs used as tables during the cleaning process. We did not observe either operator sitting on the chairs during the process on 3/11/2013. 22 of 30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC EI Start/El End: 03/] 1-19/2013 Earth City, MO 63045?1213 Discussion with Management: Management stated they only use the glassware for cleaning and product(s) to be discarded. Mr. Schultz stated it was no different than cleaning the vials. The vials are cleaned in the Pharmacy and again prior to use. The glassware is placed on a rack above the sink until their next use. The glassware beaker sizes are OBSERVATION 7 Aseptic processing areas are de?cient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Speci?cally, a. You have not conduced disinfectant effectiveness studies to show the disinfectants used can reduce bioburden on the different surfaces in the cleanroom (Class 100) where you produce sterile products including the following but limited to: Tobramycin, Colistimethate and Hypertonic Saline. b. The Cavicide used to disinfect the surfaces in the cleanroom (Class 100) (where sterile Tobramycin, Colistimethate, and Hypertonic Saline are ?lled) is not labeled as sterile. Reference: 21 CFR 21 1 Supporting Evidence and Relevance: During the inspection I asked Mr. Blakeley if they had performed any disinfectant studies to show what they use are effective on their surfaces in the cleanroom. Mr. Blakeley stated ?Why should 1, they are already tested and approved by We responded we believe they are regulated by EPA. In addition, their environmental monitoring is inadequate in that they only conduct environmental monitoring on a basis. Review of the label on the bottle of Cavicide in the Cleanroom did not indicate the product is sterile. The Cavicide is used as the second cleaning of surfaces prior to sanitizing with Sterile Isopropyl Alcohol. Discussion with Management: Mr. Schultz indicated they follow the USP guidance on this. 23 of 30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC El Start/El End: 03/ 1 1-19/2013 Earth City, MO 63045-1213 REF USALS During the initial walk-through inspection of the facility I asked to observe operations in the Cleanroom and was informed by Mr. Blakeley that he didn?t want us to disrupt the air ?ow. He later said they could provide a simulation either before 8:00am or after 6:00pm as they would need to do a major clean afterwards. He asked if we had scrubs. Investigator Perry-Williams asked Mr. Blakeley if the employees purchase their own scrubs and he stated they did. He stated employees are required to launder their own scrubs. He also said they change into the scrubs at the firm. We were able to provide our own disposable jumpsuit and observed a simulation of Hypertonic Saline lot 4HS4- 130311 late on the first day of the inspection. We were not allowed to take any paper or our camera in the Cleanroom. The design of the Anteroom and Cleanroom does not allow viewing area as there are no windows in the room or in either of the doors. I informed the operators they should operate as if it was the actual process as it might be our only opportunity to watch the process. Mr. Blakeley didn?t believe we had the authority to inspect his facility unless we had a product complaint or drug recall. On the first day of the inspection I read 704(a)(1) and then Mr. Blakeley pointed out 704(a)(2) from the FDA 482. On 3/ 12/2013 I informed Mr. Blakeley we have authority under 21 U.S.C. 374(a)(1) to enter the cleanroom, take photos and enter the warehouse where drugs are stored. I informed him it is our job to review his record to determine if he was except from 21 U.S.C. 374(a)(2)(A) that we just can?t take his word that his company is exempt. Mr. Blakeley stated this was not his understanding. He requested a list of documents we wanted. Investigator Perry-Williams informed him we could provide it verbally. Once we outlined our requested documents he stated that is everything that is regulated by the Board of Pharmacy and questioned why we need that information. Initially Mr. Blakeley refused to provide us with copies of requested documents. Later, Mr. Blakeley said he was wrong and started providing copies when requested. At one point I informed Mr. Blakeley it would be easier to have our FDA attorneys speak with his attorney to ?hammer out these issues?. He requested to speak direct with the FDA attorneys. I informed him the FDA attorneys could not speak with him as if he has counsel it is against their ethic rules. Mr. Blakeley stated he had not talked to an attorney since we have been at his ?rm, does not have one on staff or one on retainer. However, the organizational chart attached as Exhibit 2 shows ?Legal? and lists ?Outside Counsel December 2012? is located next to the asterisk. On 3/18/2013 Mr. Blakeley noti?ed the inspectional team in an e- mail that he contacted legal counsel and provided the name of On 3/13/2013, Mr. Blakeley asked if FDA will ?pay me for the drugs I?m going to have to throw away? with us being in the Cleanroom. We indicated FDA would not pay for the drugs. On 3/14/2013 he did allow Investigator Perry-Williams to observe set up for sterile ?ll of Tobramycin. 24 of 30 Establishment Inspection Report El: 3005364771 Foundation Care LLC EI Start/E1 End: 03/11?19/2013 Earth City, MO 63045-1213 Mr. Schultz stated he would have some questions for us at the end of the day. He mentioned they follow the USP <797>. I stated we were not following USP <797> for the current inspection. At the end of the day Mr. Blakeley read from a list of questions and some were: request for the FDA attorney contact information, an FDA organizational chart, asked if we had gowning/gloving experience, if we were familiar with USP <797>, if we were familiar with Low/Medium/High risk with the Board of Pharmacy, and if we had knowledge of the Missouri Board of Pharmacy Rules, Regulations, etc. He also wanted to know if he needed to ?le a formal protest against the inspection after the inSpection or before we close-out. I referred him to the FDA website and stated he should type in Ombudsman. I said I believe FDA organizational charts are available on the internet. I informed him John Thorsky is our District Director and our centact information is on the FDA 482 and FDA 483. At the conclusion of 3! 18/2013, Mr. Blakeley stated if we post our ?ndings he will seek legal counsel and come at us with a vengeance, anyone involved. GENERAL DISCUSSION WITH MANAGEMENT The FDA 483, Inspectional Observations, was issued to Daniel P. Blakeley, CEO and Pharmacist in Charge. Also present during the close-out meeting were Michael A. Schultz, CFO and Quality; Lindsay Wessels, Manager Marketing Regulatory and Regulatory Documentation Specialist. Before the FDA 483 was issued to the ?rm I informed them these are our observations by following our assignment. I also read the initial paragraph on the 483. Mr. Blakeley asked if he could ask us a question. He wanted to know if we had seen the FDA Frequently Asked Questions on the FDA website. He went on to say nothing they are doing shows their product is adulterated. I said from what they are not doing the products could become contaminated. He continued with another question. I said requested no more questions and said we need to continue with the close out. Mr. Blakeley asked that we walk through each item one at a time. Other comments made during the close-out meeting are listed with the observation in the Objectionable Conditions and Management?s Response section of this report. Mr. Blakeley asked with each observation where could he find information to comply, what regulations applied, etc. He said he didn?t want to wait until he got the report to get this information so he could respond. At one point I recommended the Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice. Mr. Bucks stated this is one of the guidance documents they could use but there are others. One observation initially listed on the FDA 483 was the lack of stability for Tobramycin, Colistimethate and Hypertonic Saline but removed when the FDA 483 was amended. Mr. Blakeley 25 of30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC EI Start/E1 End: 03/ 1 1-19/2013 Earth City, MO 63045-1213 and Mr. Schultz were adamant they provided us data during the inspection. They also provided additional data prior to the conclusion of the inspection. Due to the lack of time, this item was not re-written but removed from the FDA 483. However, the ?rm does not have a formal stability program. They have some recent stability data for Tobramycin and Hypertonic Saline. They only have a 2005 stability study for Colistimethate. Data provided during the inspection included the following: Table 3 Product Lot Storage Test conditions Results Tobramycin TA170-090721B July-Sept. 2009 Sulfate 170mg/ 3.4mL 0.45% NaCl Tobra 11 115B Feb-Mar 2012 170mg/ 3.4mL 0.45% NaCl Hypertonic 4HS4-090720 Lily-2009 Sahne 4%?4mL Hypertonic 4HS4-090720 Aug 2009 Saline 4%??4mL ypertonic 41484-090720 Sept 2009 Saline 40/d4mL Hypertonic 4HS4-090720 Jan 2010 Saline Colistimethate Sept 2005 25mg/mL 0.225% Colistimethate Sept 2005 25mg,me 0.225% 26 of30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC EI Start/E1 End: 03/11-19/2013 Earth City, MO 63045?1213 The only document the ?rm has related to stability is potency tests for the following products: Exhibit 42, Tobramycin, Certi?cate of Analysis for 2009 and 20l2 as reported in Table 3. 1 Exhibit 43, Hypertonic Saline, Certi?cate of Analysis for 2009- 2010 as reported in Table 3. Exhibit 36, Stability of Colistimethate at September 2005. *Note on Page 4 the Exhibit shows Colistimethate in 75mg/3ml: Lot 050527. They have not conducted any stability studies for Colistimethate since 2005. The last potency test for Colistimethate was in 2005. The previous FDA report states this study was conducted by of the This study was not signed by Ms. or anyone from Foundation Care. See Table 2 for Tobramycin, Colistimethate and Hypertonic Saline the amounts ?lled in January, March and August 2012 and total for the year. The conclusion of the inspection I stated any further questions could be directed to our Compliance Branch or through the attorneys. Investigator Bucks and I both stated during the close-out they are not being treated any differently than any other compounding pharmacy. I read the following warning to ?rm management: I am required to warn you of your responsibility to be in compliance with the Act. Failure to do so could result in an action including seizure, injunction, and civil or criminal penalties. Please keep in mind this inspection is not considered all? inclusive nor should the FDA 483 be c0nsidered all inclusive. SAMPLES COLLECTED No samples were collected. EXHIBITS COLLECTED Compounded Drug Reimbursement Information list, 3 pages Foundation Care organizational chart, 1 page Foundation Care 4010 Facility diagram, 1 page 8B.l2 Positive Pressure Monitoring, 1 page 8B.3 Use of Anteroom, 2 pages Clean Room Layout (and Ante Room), 1 page Photographs of employee, 2 pages 15 prescriptions for January 2012, 45 pages 15 prescriptions for March 2012, 39 pages 27 of30 Establishment Inspection Report El: 3005364771 Foundation Care LLC El Start/El End: 03/11-19/2013 Earth City, MO 63 045-1213 10prescriptions for August 2012, 45 pages 15 prescriptions for December 2012, 45 pages 2012 Compounded Products list, 21 pages Prescriptions, Pharmacy Work Order Compounding Record and Foundation Care Delivery Ticket used to ?ll from Compounding Formula Record Tobramycin Lot TA170-120103B, 47 pages. Prescriptions, Pharmacy Work Order Compounding Record and Foundation Care Delivery Ticket used to ?ll from Compounding Formula Record Tobramycin Lot TA170-120327B, 56 pages. Prescriptions, Pharmacy Work Order Compounding Record and Foundation Care Delivery Ticket used to ?ll from Compounding Formula Record Colistimethate Lot C75-12081 6, 35 pages. Prescriptions, Pharmacy Work Order/ Compounding Record and Foundation Care Delivery Ticket used to ?ll from Compounding Formula Record Tobramycin Lot and Quality Control Inspection to explain discrepancy with unit amount, 48 pages. Prescriptions, Pharmacy Work Order Compounding Record and Foundation Care Delivery Ticket used to ?ll from Compounding Formula Record Hypertonic Saline Lot 4HS4- 121213, 43 pages. 8B.10 Quality Assurance of Sterile Compounded Product, Revision 1, signed 7/17/2012, 1 page 8B.11 Beyond Use Dates of Sterile Compounded Product, Revision 1, signed 7/ 17/2012, 1 page 7A.l3 Complaint, 4 pages 11.1 Recall Procedure Pharmacy Product, 4 pages Media ?ll test kit instructions and Media i11 Testing log, 5 pages 3C.4 Compounding Personnel Training, 2 pages results, 12 pages 8B.16 Environmental Testing for Cleanroom, 3 pages 8B.16 Environmental Testing for Cleanroom Draft, 4 pages Cleanroom Environmental Testing Log for November 2012 and January 2013, 2 pages 8B.19 Anteroom Cleanroom Cleaning Procedures, 2 pages 8B.20 Cleaning and Maintenance of Cleanroom Equipment, 1 page 8B.4 Compounding Garb, 2 pages Compounding Formula Record for Hypertonic Saline 4% lot 4HS4- 3031 1, 1 page 8B.7 General Aseptic Procedures Used at the Clean Room Workbench, 1 page 8B.5 Hand Washing?Sterile Compounding, 1 page Certi?cate of Analysis for Hypertonic Saline 3%/3mL for 7/29/2009 28 of30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC EI Start/E1 End: 03/11-19/2013 Earth City, MO 63045?1213 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. Certi?cate of Analysis for Tobra 170mg/3.4ml 0.45 NaCl for 6/21/2012, 1 page Stability of Colistimethate September 2005, 11 pages 88.13 Contract Laboratories Sample Testing Frequency, 2 pages Microbiology Reports, 7 Pages Compounding Formula Record for Tobramycin lot TA170-130312B and ta150?130312A TA170-130312A, 2 pages 8B.21 Washing Glassware for use in the Cleanroom, 1 pages Compounding Area Cleaning Log, 1 page Certi?cate of Analysis (COA) for Tobramycin, 5 pages Certi?cate of Analysis (COA) for Hypertonic Saline, 4 pages Letter with replacement estimates f0] with projected air ?ow. 8B.14 Cleanroom Anteroom Certi?cation and Test data for 7/24/2012 CD of photographs taken with an FDA digital camera and of?cially sealed. Microbiology Report from for Hypertonic Saline sterility test in June 2012; Endotoxin and Sterility Certi?cate of Analysis from for Tobramycin dated 3/15/2013 and Colistimethate 3/15/2013. ATTACHMENTS FACTS Assignment ID: 1495040 Operation ID 6608238 Inspection request memo from dated 2/6/13. FDA 482, Notice of Inspection, dated 03/11/2013 to Daniel P. Blakeley, CEO/Pharmacist in Charge FDA 482, Notice of Inspection, dated 03/ 12/2013 to Daniel P. Blakeley, CEO/Pharmacist in Charge FDA 482, Notice of Inspection, dated 03/18/2013 to Daniel P. Blakeley, CEO/Pharmacist in Charge Original FDA 483, Inspectional Observations issued on 3/ 19/2013 to Daniel P. Blakely, CEO/Pharmacist in Charge Amendment 1, FDA 483, Inspectional Observations issued on 3/ 19/2013 to Daniel P. Blakely, CEO/Pharmacist in Charge 29 of 30 Establishment Inspection Report FEI: 3005364771 Foundation Care LLC EI Start/E1 End: 03/ 1 1?1 9/201 3 Earth City, MO 63045-1213 SIGNATURES Shirley J. an, Investigator Michele Pen'y Will' 5, Investigator Anthonykucks, Investigator 30 0f30