DEPARTMENf OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OAlE(S) OF INSPECTION 8050 Marshall Drive , Suite 205 Lenexa, KS 6 62 1 4 (913) 495 - 5100 Fax : ( 913) 495-5115 Industry Informat ion : www. fda . gov /oc/industry ~= 03/11/2013 - 03/19/2013* 3005364771 Daniel P. Bl akeley, R.Ph. , CEO, Pharmacist-In-Charge FIRM STREET Found ation Care LLC CITY. STATE. Z1P CODE. COUN1l!'f Earth Cit , MO Producer of St e rile Dru 63045-1213 Products This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, co.rrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above. DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: OBSERVATION 1 Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed Specifically, a. Your media fill procedure and docwnentation, which are used to ·validate your sterile processing operations, are inadequate. You failed to a perform media fill simulation, including documenting the following kinds of information: I) Average and worst case processjng times. 2) Document the different kinds orinterventions, along with the average ~d maximwn 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 Cleanroomn fails to inClude fustructions on daily monitoring under dynamic conditionS (when processing oecti.rs) in your Class 100 (ISO 5 zone) cleanroom as it inStructs f o r - enviromnen~ moJ;ritoring·only foreqUipment and air sample (viable and non-viable monitoring) In addition, this SOP does not include all9fthe eqUipment containedi.tfyour Class 100 cleanroom to be included in your~onitoring program. For example it fails to include and fail to momtor the following (this i~ .not ~ iil.clusive list): 1) 2) AMENDMENT 1 3) 4) 5) 6) c. d. e. f. g. h. plastic storage bins located on the lower shelf of one of your long tables; ..,........v vial racks used to hold your ampules Speaker located on the bottom Door knobs, walls, and floors. of your short table; You failed to perform daily enviro.nmental monitoring (or when processing occurs) of your personnel. Your SOP 3C.4 "Compounding Personnel Training" instructs you to conduct­ personnel monitoring activities only. For example:. was last monitored 10/19/2012 an~ was last monitored 10/18/2012. . . 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. Additionally, you failed to conduct a smoke study after a new air handling unit was installed in 2007 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. Your fum has not defined a or intervals where must .be changed out. "8B.4 Compounding Garb" only On 3/11/2013 during the disinfectant bottle the fill of Hypertonic Saline 4% once at the end of and once during cleaning. He sprayed the bottle w i t h placed it back on the lower shelf, continued to work and did not change his ..,._..~'""' phann3;ci~t. technicians changed their glove.s during the process and they only wore one pair of glqve~. _ , . While observing cleaning ope~tions on 3/ 11/2013 in t4~ anteroom employee. left the door between the cleanroom (Class lOO) ,fllld anteroom(Class ,10,000) o~n at least 3 times for over 5­ 10 second after cleaning/s~itization of the Clean Room. ·The door does not automatically close nor is there an airloclc between the rooms. You failed to follow your SOP 8B.5 "Hand Washing -Sterile Compounding". On 3/11113 and 3/13/13, your employees. and..,oth failed to allow "water to run from fingertips toward elbows" during the rinsing of their hands as required by the procedure. · AMENDMENT1 1. There is no clock or time instrument in the anteroom to make sure employees preparing for aseptic production scrub their hands for a minimum o~ in accordance to their procedure 8B.5 "Hand Washing -Sterile Compounding." OBSERVATION 2 Clothing ofpersonnel engaged in the processing of drug products is not appropriate for the duties they perform. Specifically, during processing of Hypertonic Saline on 3/11/2013 and Tobramycin on 3114/2013 both employees. a n . 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 wom underneath the Gown are laundered at home by the employees. · · ; . , OBSERVATION 3 Laboratory controls do not include the establishment ofscientificaDy sound and appropriate designed to assure that drug products conform to appropriate standards ofidentity, strength, quality and purity. Specifically, a. Potency is not performed on a routine basis. Your procedure 8B.13 Contract Laboratories & ........ua"" .t•requc~ncystates be done on basis or at the " For exiUilple: Hypertonic potency was last tested in July 2009. Tobramycin potency was last tested in December 2012. Colistimethate was last tested for p()tency in September 2005. AMENOMENT1 OBSERVATION 4 Each batch ofdrug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, you do not perform sterility and endotoxin test on a routiile basis for Hypertonic Saline which was last tested for sterility in June 2012. OBSERVATION 5 The records for components and drug product containers or closures do not include the supplier's lot number. Specifically, a. b. You did not document the lot number ofthe TPN bags ~ed in the st~rile. dnt.g process for the following but not limited to: Tobramycin Lot TA170-120103B, TA170-120327B, TA170­ 121211A, TA170-130312B; and Colistimethate Lot C75-120816. 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. 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. Specifically, there is no documented cleaning of the glassware prior to tJse 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 "W Glassware for u5e in the Cleanroom" instructs etn}1loyees to After the w·as.h:ing;'dryin AMENDMENT1 instructs them to This. is located in the anteroom (class 10,000) area which does not documented of this storage area. We observed this practice on 3/ 1112013 during the cleaning process after the sterile fill of Hypertonic Saline. OBSERVATION 7 Aseptic processing areas are deficient regarding the system for cleaning and disinfecting aseptic conditions. the room and equipment to produce Specifically, a b. 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. T h e - used to disirifect the surfaces in the cleamoom '(Cia8s .~l 00) (where sterile Tobramycin, Colistimethate, and Hypertonic Saline are filled) is not labeled as sterile. *DATES OF INSPECTION: 03/ll/2013(Mon), 03/1212013(Tue), 03/13/2013(Wed), 03/14/2013(Thu), 03/1812013(Mon), 03/ 1912013(Tue) The observations of objectionable conditions and practices listed on the front of this form are reported: 1. Pursuant to Section 704(b) of the Federal Food, Drug and • Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration Section 704(b} of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: "Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food, drug, device, or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2} has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."