DEPARTMENT OF HEALTH AND SERVICES AUUHESS RND PHONE DATES: OF 466 Fernandez Juncos Avenue 4/5/2016-4/28/2016* San Juan, PR 00901?3223 (737)729?3500 Fax: (737)729?6309 3004369315 NAME AND OF Tl?i WHOM REPORT ISSUE: 1 Mr. Felix M. Negron Vice President of Operations FIRM STRFE SH Medtronic Puerto Rico Operations Co. 50 Road 31 km 24.4 Ceiba Norte Industrial Park CITY CODE TYPE ESTAHL litiHMEN'l - Juncos, PR 0077? Medical Device Manufacturer This document lists observations made by the FDA representativetsl 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. corrective action in response to an observation. you may discuss the objection or action with the FDA representativetst 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. The observations noted in this Form FDA-483 are not an exhaustive [isting of objectionable conditions. Under the law. your firm is responsible for conducting internni seiflandirs to identify anci correct any and all violations of the quality system requirements. DURING AN INSPECTION OF YOUR FIRM I OBSERVED: OBSERVATION 1 Procedures for monitoring and control of process parameters for a validated process have not been adequately established. Procedures established by your firm in order to challenge device conformance to specifications do not encompass required product testing as in related process validation activities to demonstrate that pre- determined device speeifications are sustained and continue to be met. For example: A. Performance qualification report (4) (4) . dated 31 May 1 1, documented the validation activities for the sealing process of your implantable Synehromed II infusion pumps. The validation activity encompassed required product acceptance criteria to be (4) (4) Nevertheless, procedures implemented by your firm to challenge the output of this manufacturing process and as established under (b (4) 'Il SynehroMed Inspect Sterile Package. SynehroMed required acceptance criteria to challenge the output DATE SEE REVERSE Laiza Garcia, Invest' tor 4/28/2016 OF THIS PAGE :7 FORM on INSPECTIONAL OBSERVATIONS \til-. i ui .. \oi-s (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) (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) DEPARTl\>lENTOF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRA TION DATE(SJ Of INSPECTION DISl RIC I ADDRESS ANO PHONE ~UMBER 466 Fernandez Juncos Avenue San Juan, PR 00901-3223 (787) 729-8500 Fax: (787) 729-6809 4 / 5 / 201 6- 4 / 28/2016 * FEINUMBER 3004369318 NAME AND TITLE O f' INDIVIDUAL TO WHOM RLPOAT ISSUED Mr. Felix M. Negron . Vice President of Operations FIRM NAME STREET ADDRESS Medtronic Puerto Rico Operations Co. 50 Road 31 km 24.4 Ceiba Norte Industrial Park CITY STATE. ZIP COOL COUNTRY IYPt ESTABLISHMENT INSPECTED Juncos, PR 00777 Medical Device Manufacturer MPROC", in order to determine the reported impact of the confirmed non-conformity and to discern if process controls were in place to detect and orevent the reported non-conformity by reviewing the PFMEA for this product family. CAP (b) (4) lwas initiated on 22 Jul 2015, to address correcti ve actions necessary to prevent the non-conformitv and to contain affected oroduct. The CAPA investigation documented that the source of th~(b) (4) Ion these devices was (b) (4) J 1mp1antable tnl us1on pumps. At the time the product impact assessment for non-conformance-(b) (4) was initiated, the related PFMEA did not contain related controls in Qlace or the potential failure mode for the reported out of specification result ofl(b) (4) !with these finished devices. Nevertheless, the impact assessment did not document the lack of established controls and/or the addition of poter-tiaLrisk.- and...failur~Q.des ·t ·'ill.dated LCLthe renQ.rJe.d OQ.11.:foo(ormit.Y....I.he.EBJEA_ (b) (4) was updated on Corrective actions irnolementcd bv vour firm includedl(b) (4) (b) (4) lbeforc product could be released. The product impact assessment was revised on 20 A pr 16, after this observation was brought to your attention during the inspection. Annotations to Observations Observation I: Observation 2: Observation 3: Promised to correct Promised to correct Corrected and verified *DATES OF INSPECTION 4/05/2016(Tue).4/06/2016(Wed),4/07/20I6(Thu),4/08/2016(Fri).4/l 2/2016(Tue),4/ 13/20l6(Wed),4/ 14/ 20I6(Thu).4/15/20L6(Fri).4/18/20I6(Mon).4/19/20I6(Tue),4/20/2016(Wed).4/25/20 l 6(Mon),4/28/2016 (Thu) EMPLOYEE1S1 SIGNATURE SEE REVERSE OF THIS PAGE FORM FDA ~K~ (119/08) Laiza v Garcia, DATE ISSUED Investigator l'KJ-Vll)l 1S l:l>fl ION I 11J\OIJ• ll J/y!t x INSPECTIONAL OBSERVATIONS 4 / 28 /20 16 l'A(;I ~Ill 6 l'AGLS DEP RT IENT OF HEALTH A rD Hl!M A. SER\'ICF. IOOD ANO DRCG AD!\IL'llSTRATION Ol:STHI .1 '""'"<'°" ANI ~HONl DA TE!SI 01 INSPECTION NUMBER 466 Fernandez Juncos Avenue San Juan, PR 00901-3223 (787) 729-8500 Fax: ( 787 ) 729-68 09 4 /5/2016-4/28/2016 * 3004369318 NM' AN, '1TU DI- lt