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tonm21397 oscars 2013 ‘Tetabisianent Taxpactiua Report Concepts, Ine. Moma View, CA 8404-1530 SUMMARY, iuitiied this inspecdion of amumasciier af aye 3 pormancatimpaauiole connansplive deve ‘indicated in ansoniaace with FACTS Aecigumaxt BO76539 as pint oF SANL:IO's BY "12 sworn foc medival dovivess Lwadurted thi inspection pursuant th CP-7382.845 uuder PACH S2R45 and BOI. Previous ingpetrion ou Dee. 2010 to Jan 2911, covered Camedtive end Pravative Actions (CAPA) sud Munag.inenl Cost, That inspection’ fond thatthe in yas act repurting as MLR ‘complinls in schich the prodt nigrated ftox the Sallopiau whe inl Ue pertoca canity, ‘for did wot cca Uae wns i Une rine arly far the dsign of vie rhc, and dhe lia filed ws document CAPA activities for a gpplier anréecave acts. Thatnsjero Wi classified VAL Coes, Tuc. 531 b Becky Ave MManisain View, CA 94041-1530 ‘580-062-4000 65036014720 331 Evelsn Ave Mouutain View, CA 94061-1530 Dates of inspection: 51802013, 5512013, 63:2012, 6/2013, 6/5/2014, 66-2013, 6°729013, 6002013, 6711/2013, 622073, 61 42W13. 6/172A1S, 6252012, 6262013 Days in De Ladle 14 Participants: Tir onhy €. Gems, lavestigator in Wingy 22, 2021 anugunced Hs inspoctian toy Henry VDishon, Quality Manager. Cin Mas 2013, {showed say erademals lo and issued * FDA 482 (Natios af Inspection te 8. Keith Grossmann, President & CEO According ta his arlssion aad Dust uC al of the fin oFfvials present atthe cpering moving wis daeusustrcepoasible peo in aye at the start of Ge inepection. Doing de cwsreutiuspection Chnceptis, Inc. was aeyuited by Bayer Heslcare Peurmaztnr Division. tthe dose ofthe inqpention Mr. Gromraizin wen eongultant contrestec by Raye. The ‘most senor manaarancat cftcial onesie bythe clase of re inspection war Tosogh G, Sharpe, Hcentive Vive Hosen This was by tae adulssiou of M= Sharpe, and? Mr, Bisham. Aen the ‘lose of tis inspection fhe firm wus presario move Their eadqpamors over Exe Frat eek of July to dhe new addcera rats stabushmeat Inspection Repart rea 600221355 EISues useoao yal 1330 Eat I6MAOTY Concerta, es Mourne View, Toseph C. Sharpe, Excew ve Vive Preside 1101 MaCanby Blvd. Mijas, CA. 95035 Current epectfon ou July @ us LL, 2008 unsere CAPA uid Design Controle, ad reporting of urs, 1Lusked firm officnls if Concapens. Ine. a bad any reals ox Held couscdlons since Tanuory 2011, Hoary V, Bisbp, Quy Mamuger, tld me tht here havehoon no recall or eld comictacrs i The pas io yes JLresicored the Finn's procedures or anmplaint Trofuet Returns, Complains: Hanelting and Reporting SUP 1630 Rev, AB (i/88/11) MIDR Procersing WH UMSUG kee. F (8161) rcqusstod fre complete list of crmpuims ee Tamuary 2011. Me Bishop provided me wich a CD-ROM with an Pos! flother anaeatned 16/047 exis for cumplinl. Ile alzo pide me with lis of Mike. | toqnesiad and reviewed [1 zuxdom vouplaint forms CBliwiaisl Staal Sampling, Plas, Conliduoe Lint 19 ~< 0.25 ual), Trequestel and reviewod an udivional 18 sraplaiat cin. The adam compli terms tat reviewed orntsined the keywords, Spetitouea!™ or ‘alimind” emry with “pain” o1 preenuney. All of Oc couplsns in Woh OBE OL muone eins were imagrel ontsiis of te elopisn tubes, ha] dacumentation atthe paticut wis no -ab lst ona — ‘Gupecieusing pa, An sich thoes complaints wate notrepainad as MDM. “The pregnancy complaiats that {looks st weie lhe ues ia which the petcut choxe te cunts te toguansy. Tasked Terry V. Bishop, Quality Manager, ihe Soa ns ata on the utes ot ‘preymancies that hag gseuitedaficr Pass plaament, He said thal kre war 70 data coupila hur ‘and hs finn compte dala me (Babibit 1). This gr was compiled thom 132 complaints Tbolwoen January 2011 uid Murch 2013. Three nf fhe eeorics auc “a the patient plan at ae ult sonlact hy Cemsepine “Plan for ive bist, "plan fot modiead teemination’, snd “nbdeeidad”. These othr cafegouies wore fer Laowa vuteoaue uf Bee pregency’ “Medica ‘cemination”, “iscmiage", aud “Live bicth cheeihy, uncomplicute). | searched far sminsariage” with “migration” of coll or coil in weras" andl found ne rm, Tiollowod up on 3 HDA Cozsumer Compisints for Conceptos, Tae These samp vere enfort inte the fun’s dala bere fro>r MAUIDE. Tiiese eauplits were ussegeod porte firm's eomplaiat nding prncedurss 20f8 ‘Establishment faspection Report Fut 000221387 Cemeagtns, kw. ha Sears s30303 Momatain View, CA 94092-1530 ELEnd 626/200 viewed thorns procadine for Cometive and Preventive Aotion, Ceneutive and “revearive Asieus SOP-A09%5 How. U (22/10); ?saviewer she Fat of ll CAP.Ax sinae larmaey 2011. From, Oia lst} aclosted 11 sodear CAPAs Finomis! Stned Seaapling Plan, Contifeace Limit (.98 = 0.25 ual). Four theme CAPAs wove sl CAD.As open in mapas tothe ohservahods of the ‘eviouisnepcction. Fh currant inspactinn Seana! op hjoctiourble candies tick CAPA syetcn, noc the previa imapetion Conocps, lc. as lad complete te fll pest desir. Poe design contro review | slune te rain lve DeiDE (5: Ye This prods cseeatly between TEAR oan. Traviene tho Sllening dain yrseerner: Procuot Development Process son eure. . Leased te design sary ene ay ‘eins U4 The. nevi desig : 5 (TLS isa beodoc! orb a sad} 8) tee. Tala neviowad the Risk Marugerent Plar(B) (4) 50° S (Behl Sine the provious idepoutem the omutt Chief Executive Officer und Protea, Mark M, Siowlard ‘was replanted with D. Refth Grossaaua (Bait 23) Uy the soso of a iaapeetion Conte, Tos. ‘uk purtbnsed hy Mayer Healdheare Pharmacemtcal D?ision, Mr. Gronameta ws ecmeullat Atrhe alow ucLuseeting om Sane 26, 2013, I diseussed wit fren management rose tit: exthusior of 6 asienten for safety of uous veils ineide the pornod cavity in Risk Maiagetcent Man BOAAE os 1 The was ene of heabserestions trom te previous inspection. Henry V. lishop, Quality Maager, tol nic th the FMEA does ive perfsraion (Sxhibit #2, pages I anil 2) aad cxpulsion (Exhibit #, page 5). AML oF Ie obwervutions fom the previrus inspection had eos corested. | wanted fini officals presemt tthe clore.ont reat as nn even tibugh Twas st ‘asning 2a DA. 483. that das not maan that trae cookd be, al heir frm, adiliums sbi ay be objectiosséls. l warned oF poudlis Jor vidation wf dhe Pa, Dg, aad Cosmetic Act. EXITS COLLECTED 1 Pesguuncy Report Vat 2. (ON) SeDerign FMEA fit (44 pages} 3. Organization Char: for Concepiuy, ne. Senior Mlanagemicut Team ATTACHMENTS L TPA 482 (Notice of Inspection) HEZ?E Jeg Bis ‘Timosigeer Grom, Iuveatigan