Table Of Content

Kstablichment Inspeetion Report ev owu2a4357 Coneepms, ine, I Stat 12/08/2010 Mamutsin View, CA 94011 EID ouosizart TABLE OF CONTENTS Sumpary. Seusisedve Dua, History Tnteraate Comme. Ibvisdistin, Reepomeibiy aud Persems Inlervicwed. F's Traicny Progear: “Marufseturing’Disiga Operations. ‘Maacrueing Codes Coniplaints Revall Procedures, n . Objectomable Conditiors ané Management's Resparne Retisals. a 14 Geoeral Discussion with Management a : sel Samples Calloct0d.. 7 Is Voluutery Correetinmssn rennin 6 Exhibits CoM ess — : ita Aackonemts n SUMMARY “Thin wana fur-curse inspection ofa mancfastarsr of class II implantshle centrceative device for sworen. FDA foreign inspection of the Lim"s vontrect arufacsic found that ‘he sole product wf Conseptas TL cosduered this iaspestion porsvaar to CP 7382845 vader PACs 825456 and R11, # part of SAN-DO's FY °1] workyJan f5: raedieal devices ag PACTS! ‘Assignment #1246754, Previous inspeution on 7-1 12008 ewvered CAPA snd desig Controls. Ne sign'feest lservatioac were mads and en FDA 483 (haggoationel Obssevclians was sad, (Correa inspection en 128-14/2620, 12/17-24/2010, and 1672011 covered sll major quality subsystem, During this iaypevion, 1 feud thet the Bua vie uo sepoieg vomplaint oF thet product (a manta coil) being seem madiographicely inthe patient's ahdomial cavity. Tf that the firm did rot have a risk analysis fc vols being i the skdlom ua cavity ale! fond thatthe Erm ‘did nol pon e CADA wer They became ansare of their vantruet manu fueture Loft festxblistzmuw Inspection Report ii 10009221387 Conceptas, luc. Fe Start r2ip2010 ‘Mountain View, CA 4041 ELEré: a16at1 Fisted these observations on au FDA 483 that Vise y the firm's ‘president af the loss oF ie inspection, tha tinn epend x CAPA foc their amraser’ ce, wid Me. Monty ¥. Bishop, Quality ‘Manager. preauisel fo a@ coi in the ahdomina cavity to thee i analysis, Fim ofliia sai bul they do nat beiievs Him complaints oF izes that are nw: deel cesulting eu their procadtaed ‘esauplornane coils inthe sbdorsinal eavity should not be reported. {collected two documeutary wrnples: DOC14%22, documenting the shipsnent of the frm’s product Hom their wonsract maalnuroree" to stozage for d'seibution i iad and acknowsedgea by Mi. Pemy stop, Quality Manager: and DUCMA'3, dormneutiag the receipe oF cuniglsints of injariee occarsing during the procedure for their produer and their procne: belay lacabed in de abdumninal cavity, voviied and acknowledged hy Mi. Ecward €. Vt, Viee President Clinical Reseereh and Regulatory Ai ADMINISTRATIVE DATA, lnspected firm: are, Ine. Location $81 B. Bvslyn Ave, Mountain View, CA. 94041 Psu! 150-962-4000 TAX: £90-691-4737 Mailing address: 331 F, Tesh Ave, ‘Mountain View, C4 9401 utes of irspevtion: — 12:8'2030, 12°9:2U10, 1230010. Lz12010, 191499, 12APQU1O, 12-902010, EL 2014, : 4011, SIE, 82011 Days in the fied: 11 Participants Timwihy C. Grome, Investigate On Dev. 8, 2010 presertod my credentisis and thea issued an KDA 483 (Maticcof Tagection, Att Leto Me, Mark M. Siver'wel, Presideoe & CLO of Concoptus, Int. famed sauihor EDA 482 (ate 2 w Mark M, Sioorkecvs sim Fa, 4, 2011 after a broal in “he inspction at mor ta ume week, On Jan. 6, 20401 ised an FD: Mark Mt Lurended the FDA 44 ‘olering the reference to tbarad om documens showa le ane hy fina pei sonoel alh> clase-oot meeting. ‘Because of a fechnieal problees wits mboETR, Thand wrote the anaisatiors to (ae FDA 48 Ratublishment Inspection Report FEL 1000224357 Concepmas, La. ¥) Sten 12708-2010 Mountain View, CA 94041 ELEcd 1.622011 HISTORY G.Tehart MeCarthy, Sonia: Direein of Operations, tok ne hal Vonveptus, ine is a public ‘sorperation. There Bave been nn sighicivant od aces comers esi the pov isianogerinfoeenod me its he fim id that this year the im hed a plane] 6, 2010 Mr, Bishop told ms that ‘ould complete tho inspection, Ou Dee. 21, 2019 shan Ttold Mr. Bishop that ( vivald need anoth tovo to four days fo emaplete the inspoation, he reqeested that I pontac the inspection uml Yau, 5, 2011, All varesponveuves to this lew shard bw ina te Mur M, Sicezlicel Presideul und EO Coreapnis, Ine. 331 B, Dvelyn Ave, ‘Movatain View, CA 4041 690) 942-4000 This frm hos never had any ceyulatary avons recommended as the tesult of mevons inepeciiogs Anspectens on Yi21-22/05 and 79-1 148 were elasifisd NAL, laspestionecm TRAE anc 625° ‘7940S wore clossifiec VAL for failure to enulyze all cures af quality taucatiun toe ermoctve ad preventive actinne for lulure zo follow their precoduzes for control uCuon-szmfonming maceral INTERSTATE COMMERCE Conceptus, Is, no ‘enyer maunfactures it owm produc. Alk ofthe Eesure305 2its sre meauutured ser tendon, and stored Lor distribution at 1G, Rubert MeCaithy, Senior Dizector of Operations. th Mr. Henry V. Bishap, Quality Manager, of Conceptis's prndusts wore mamufuon Since thon ao pradueis were being received by Comeeptos Voallsaued DOC444332 with an afFdwe't of Hoary V. Bishop. wh ex Coneeptus takes owne:ship of the asemvled, pro-teritid device lit Comarees atin er sleilizarion. be maces ate vent Bort? stabtishment Engpection Report FUL ‘Concentas, tee. =U Surt: Mountain View, CA 91041 EIEnd: O1/06;2011 1G) Sey are eld ir dba sent Shipton 92000444232 docursonts the sale vg JURISDICTION Goecpu Fe. sls any ene pode ine sav 3S peananeal hint ceutad system. the Koare was proved as PMA 7020014 wu |1:4°2002, Phe latest supplement S28 ees aprora! eT The eownt model af Enoursis FSR IS. Me Henry V.Lishap, Qualty Maaeger old etka ad SGjizs one proviouc rode, ESS7OS, has paca th exptaton dt. The Eee crilized packaged in Bits of res cathler-orile cack, Tach kit contins fabeling, aed Te catheter w:th tn ool tached at the en ula plicemt wit, Al Abin is ee eded DOCHIS%3 INDIVIDUAL RESPONSIBILITY AND PERSONS INTERVLEWED aid nor pte-announce his seston becuse it-wa a or-omtse inspection. During Uris uspection Tad contac: wid he flowing people: ‘Mack M. Siguharek, President anu C14 was presen: at Uw apsuing und close-oot mostngs, Lissued him the FDA 482.0 Der. §, 2010, and an Jsn. 4 2011, and 1 sue to him dic HDA 48 oa Jans & 2ULL. After issued the FDA 482, be directed sae tn mabonvinates and excased hiznnlt itm the ‘agpectio, All flan peswinnol identied Mark M, Siewrkarc, Presiden and CLO as the mast exgmsible Person x vtarge, Ie accepted ths NDA AR2 tous and the FDA 483. Aer] insued the loan he ‘scoured Kiuiself and delegated hin employees in discoss the pariculic items. Ver | ananttod ie FDA 483 Thao look fori atthe fram order te wMiial sive nie the annersied FDA 485 sward C. Yuu, Viue President Clinical Resoatch and Regulatory Affkns is sponsible for TDA. subrripsious inchnding 510(K)s ad Mavical Deviee Repasls (MDs. He ropons dicot te Mork M Socakarek, President and CEG, He was pressnt a he opening and close-out moctingy a fer part ‘of the inspection as he provided inZormation on coraplsintn and Medical Device Reporting He provished me with cupios of docurems lial eupported che it’s decisincs for MTD, On Jon, 6 2011 he signed an affidavit identifvinspeorvet complaints (DOCAA323}, Heute V. Bishop, Quality Mangeer idenilied himself asl wan idouttfed asthe manageanumt seynescatative, He us espunsibiity foe tre appliomiun oF the Quality System ax i upplics iy CARA. and Design Contr: and the oversight ef sontict processors. He reporls in G, Rebut Meanhy, Se Dir. of Ope:aions uring dis inepec-iom Wr, Bish wns my primacy Sm eoutaol thronghout the ‘tspection, He was pessent sith me tbraoghout the tuszection excepe whon he was perscullyrericving mtneated rounds ot documents, He either providod me with noyuestel records end doctuneews or he directed Sis assistant t du so. 9 Jan. §, 2011 De signcd an affidavit identiyang secur showing iene shipment ofa “ot af Here DOC444352), 5. Robsgt MoCarthy. Seniar Direenor of Operations was press atthe opening and close out vesetings, Heissesponsible fhe oversight of conleaer mannacurees sad steelers, He povided tot? Establishment luspestinn Report FEL 1000221357 ‘Cacepiun, I, TI Stan 12082090 Mowituin View, CA 9408 He Eu OVO FLL ‘nef mation = te aeivitien of tae Cum 'a uontract mamaduturges, He seports to Gregory B, Lichtward, Fxocuive Vee Fuesidert, Operatiags, Chief Financial Officer. ABURSRUUNUDENANIGII a pce opin en lott mcoriage Te wosks fer Ronry V. Bishop in yutity. He was present forthe iaspeccion, assisting Henry Diehep ou 13/8. 910 aud on 1411, SQEGTHEL MLD IGAT TREN sesh asset sir g Heany ‘Bishop on 12/10 10 12°21/10 and on 1/5/11 and atthe close wu mcettg, Fle wreaks for Mey ¥. Bishop in qualny, os musr-oved on 122972018 cancel ‘conversators Wi the contac: manvscire «iii is lereporis te Terry V, Bisp, Michael G. Reddick, Prndost Surveillance Vanaper vias preset al the close-out mestiug, Me reports toldwad C. Yu BIRM'S TRAINING PROGRAM Tid not review the t's exployoe taining program. MANU ACTURINU/DWSIGN OPERATIONS Comertive aud Preventive Actions: For my review ote finn'x CAPA subsyscciu Tack at Complaints ane Nna-Conforming Muterial Review, Mr. Reuty V. Bishop, Qusily Manager provided mo wiih necpy of Contetive and P-everrive Actions (CAPA) SOD-A934 Rew. 1 xhibit +1), He alco provided me with the ulber SOPs: Non-Confinming Meferis] Reiew SOP-04083 Rew: AA.vwd Pindact Rewum, Complain, Handliag, and Reporting SOP-1620 Rov, AC! (Ebhibit #2) | cequested 0 review random I out o° 14 CAP. 2015] ovited me ‘ith the les for 1J CALs, Ffinmd ao exception observations with 10 ofthe I that L reviewed, eet ge i ER estos CAPA setitiesconocrsng cat fale: CAPA O014 ws opened em 12510 fo dtacur et fiaores towed dang Jot (GNM £88205 (Eman Tages hod & Vat the box ad fo oo! eae aralyes. On 1221/10 Hemry Hisop th additional informatio in a prntont oF easels (Exhibit #4). That Corrective Acton Fy 1 arked Heary Bishop if Conceytus bial upened ing of thd Psfop fold me thet al issues suf IT Eeseahiishmenr Inspeetion JReport i 1900221387 Concepas, tne. ELStan: 229822016 Miowvain View, CA 12041 Td: 01-0620 ere neumnted ia CAPA G14, On 127202010 he toil me that be sald be envered valet CAPA OUT4 andthe specific NUN APA. That CPA wap ted a ecponse {En 483 Observanon #4) eagn Controle Since the ast Inypeston the Hm bas net dew the latest Henry V, Bishop. Que iv meger provided me w:th copy of Risk Aaalysiy Desion TMEV bist 4}.1 (his droament ix expect tothe Grane porting os MDRs exmplatats in which: the coil hud grated is tse abicoxniend cacy. AlERough, hate is urefirones <0 pesforetious as a pussible effect of 10 fhe mode ir the cuit being too al pperdovation itself sud the possible col ia “he ahacmnal cavity uu analyzed asa fsifwe mods: “See Ofjectiousble Conditions #3), | seviewad the [test PMA seppleucents: PO2607 4/420) Real Tite Supphaneut Dry Paw Velvet Intreivoer Changes ane Addi oo « on 2/23:M8 (Smerdrae: #1) which included Validation resting, Adlition off ‘508 (Amendment #2}, Changes tc Delivery Wire Holewr 95°08 (Amendment 73). PO20014'823 Delivery Wise Holder Je cace Bend ior detachment tiaing change 99/08 inclu foe ‘To Zollow wp om the product failure that le? to this for-cauoe iespoctiom, Trecuested dacomentation con all va design activities en cening diffion. fy to dcaloy wine. Tenry Rishop told me tha : changed ite proces, Mivtaueanern Controls: [reviewed the documents Munageoncut Review SOP-01 102 Rev. n.emal Avsit Proceduse SOV00415 Rev. AB, Lroviewec he revonds wign-in stet for th Management Review “3 1Lovlealulthe Tntoraal Andit schedule fer 2010. The Be 1 lewd ne ‘objectionable conditions inthe tey's ramayercnt contre, Production end Progessiny Cools: During this napestion Lfisuad no evidence Ba the frm wes ‘Sseibuting Lots st had fale vesting fr deplosment fore. Tknured che tina's weeiving ares. 1 obscvved the hoxes u! Esstre Thu wets boing held fa quarantine. | eouuted all the boxes, and ‘compared nry connt with the number of pruduet litiad Tocuntcdli Accordiuz 13 (exlubi 65 hore ew tal ef] ots that hav the disposition ls were hele Jor rte lols passed teaang, Me, Bishop told metaat bse] | ots which posse eae dst etimeoftis 6or17 Establishment Inspection Report Fu: 1000221357 Concepzus. bs ELStau. 1BORING Mountain Views, 24 94041 ELEni ov-¢6:2001 inggectin theve devices wore being kel st Cor us, Ine. in Muunuain View, CA ‘the quaaatine Tlenry Bishop pruviced me with a oriptot of 3 4.6 by Locsfinn (Hshibit #9). This record is dated 12/2010, tstows tha sols Ente and give u (ula a{illbanite, The shipping baxes axe proks oss. The inventory acount for all the boxes With partic eunén “ne vuils removed Atte tne of thie So Oe ana pvt CAR CAP oes Sscuncands pate MANU KACTURING CODES -Acconding te G. Robarl McCarthy, Sealer Diector af Oneretiots Coucepm, Zar has its vontract ‘manefucuscrs asin Tl nose. ‘om that coatras! minafictnrer include apumber soon lens a Some int asters of devices COMTLAINES ‘My inspoction uf the commple-bt seater af Concepnss Ine, Sate ta the Son was mot epoeia ‘complaints oF lise nict-insert cous in de peitonex” ax abdauting pelvic cavity (Soe PDAS Observation #2). Seme slaoement proved aren have a porforation of the fallopian tubes. ln some of ‘hess cases the miero-insert cui ll muigrate through the peeluration in de tbe al vA] be found ‘on xray to be outside Ue female reproductive tact te peritoneal cavity. Such vases will be repormed as MDR by the fir ifthe suieat és complaining of pain and! x accond provedute is Fecuited to remove the coil, However, tho frm nll aul epset ach complaints if an able located coil is raauved daring Flapamostupce bal Fgaien peelonised eczuse cf flue nt the Fssue procedure. Toflt stahlishinent Tospeetion Repurt FEL snoe221387 Ganespms, ln ET Stat: fomnse2010 ‘Mouuteia View, CA S04 TITnd: ano Lfenry V, Bishop, Q.udity Managor peovided ne witha eazy of Product Retum, Comp! aint Handling a:d Reporting SOP-1630 Rev. AC (Exhbi #2), Work Ios rustion WI-OS19 Meeal Device Vigilenoe (MDI Reporting ( ixibit #1), aed Wenk Iirustiny W1-03396 MUIR, wit im Lscl sprouse hall of te complex opened ance seo eee ee xml cs 14°08 oi 120 ine Theron IES ADs oped ne eee ae pod The ese! mveadtet or w empl deal uve doled dereloel he evca Heese Bishan pre te mare dtd coups spree nem ELSES oe CD OM labeled {HINDIII thet stats at 7-20°2016 end goes to 12002010 Tae ‘otal ther a off alo Fats ee lad ssesned Leese al 8 Cfenplits fordeu sent lity ty in, | fooked at the ccmpleints lr perdoration ¢ting the pravelure on th atnas. | noted that nem of the perforation complaints were rcaotted aa MURS. puke wrth Eeivard C. Yu, Vies President Clinioa: Rercarch and Itegalulory Aiki, shot: perfication woanplainss. Mr. Ve gave mea copy of Cowespuudeneshetwen Cusep'us and FDA concetning PMS PORUDIZIRAIAA March 30, 2004, Deca ofthe finns cowsmuniaton wih COR omeesing errata sforancn a ke Faller res nd tench uy ann the oi Sug urd iss oul ea Seo FDA Omwrvatone! au), jor emmod fe ee on AZO emer on pane ta the cor aa tea pron Snm tyecomplaint databese oof a (Couples tna P2801 <H4201 na oT oad tou coolant cae athe Smal ety ue wi abet passa plowed ove oe at pls at oo thaifed as Wok reposahle Soe LDA. Otser are an) RECALL PROCEDURES Haury V, Bishu, Quality Manager pave auea copy of tie fa:'s Pinduut Recall SOP, SOF (14S (Enhibie $12). Me, Bishop told mie-dhat the Siw has ay. had a vee] ino the lst ingpection. OBJRCTIONABLE CONDITIONS AND MANAGEMENT'S RESPONSE ‘Observations listed an form FDA 483 Soft Estoblisument Inspectinn Report FEL 1000221357 Canoentas, Ine, EI Stat: 12082010 Mounte View, CA 2041 TIBna 01-06;2011 DESERVATIONT ‘An MDR report was nots somirted within 30 daye of reviving o” ntherysise becoming sviaro ef infoarstion that ressonubly suggests hat a rakcted devive may have cuusea or eomtsfnte sat «deal cx rious injury, Spells he foie enaysiny roma 1, 20104 Mos 10,03 rpm cle! pecortom datos tig the ere ple es a MBI and asc ee oF 1128306 Pesan: Po s7o: pln: eke oat explora lepaoseony. eoon nls 22202010 ees patient ed bel petra lesen berry Feil Iyplecetom 2ARIMII cr artaae te 2162510: Wh "toate ho ost an. She petal i ies Bowe vor stemplel ts lace second dace, sh asd grapes lett contelsintthe tins device ao cy exe au ba ite yr fe we recited ea Iatos:epean: vitzain ra oan. here were 4 sonny oF pve saieaInew Huy 17, 2ec0. om 10,301: the above coesinns worUaonly ys Of 1 Enno petraion ee bemes-The efor ‘onplins veo fer ua lean tis, ‘ere was. one sniehnt sht ws t r peoston be whi CT aon win ‘with eee ce pleas mgs of i ub tenet fea a he Bowe DN id ve 11-9570. wove ds 121 Fiat segura em epee tng te BH Bo priced dove on 11:19 Posounad 31 soa which revelation es 9 pln pe) Moras howe] Flin sane paren erat towered al arse in in hema pt dal rye Taten Annncinn: Proandsed wo errvect by Jan.13, 20LE Reference: 21 CFR 894,50{ah 8) Jdenge and elev Suanatiny woe! The esucttion i ony Fou a old me on Jun. 4 2011 that Conceplus, lu, has decid 1 eopor tis com gltal xs an MDR, I celleted all three complaint dle es 1OC444337 wit [NN ct 2), NE tc 43), and #8 d0ctes095, an #2) and LIED OC 442853, tL 43} bok weeeeorenlonts involving a perforation oy sugpecacel perforalioa af to bowel, Both cfthese complains favelval an iseument thats not uanufuctorce3y or for Consuplas, Ie. Tho iusttcisls inolvee were rot specially calle lor in the Basure Fsbuctiony (or he ((7OC 444332, A. 1 Ne rerfation was eaased by the hystexasoane hal vine sed lo visuah7o tho opening of the fallopian (ube or inststd by the Fnimctices fore {J ]OCH443532, it 1}. (Cnceptus os repostod commplints jn wich the eofl was found eutsideof the tlNopien tebe in the abdorninal xy, when there we reper of pa tbe wach the coil is wusyiswly ot lyparescepically vetlt Ustablishment Inspection Report Tr swo022i357 Conoepien, Tne. EI Sat: 32:08:2010 Mountain Visw, CA 94041 ET ins tera: emovco{0NNINR incident date | 1/05:2010, iii! reported that one othe ooils was soen hn fo lever, one uf the pisses betes the eters and he bowel, ad (hepatic sras comple ing Bala. The Antal report was that scrgers to veriove the enil was being planus. REE pe meavepy oF tke uplued fle eENTMon Jur. 56,2011 Qeshibit stay “the update (pape 7) shove al the coil seen the wbdemninal covity was bu piece Esparescopic removal wax un poetarmed 1 [2182010 2 days aborche ina senen Rabwrd ©. Yutold me that Camenprs seal sn MR fi ce uecvisiom only angles 10 t's compel Discussion wich Mruapenens: On Jn, 5.2041 Mr. Yu tld me shor the Cecision w repou NT MEE aves on the updated infurmation, 1 ssie that Wwe information that tae fine hed IBZ, when the congaint frst was received by Conceplus, > apakea decis oa to tepunt, Beeause te rm Juss sepurtine this coraplsfa: | santated tae Ohservation as vemised 9 comect. i. Fu told avo thal wuld vet be reported bacause the deviees that wrece responsible fr de ‘juris ware not made by for Conceptus ‘OasERVATIONZ AGMDR repost vis not sebvnited within 34 éays of seosivig ov otherwiae hecomiy ware of {nformatiou thw setsoua'y snapesis that» morketed device aw malfanctioned and wet be Ekely ‘to cause ur vontrinne fo dealt er serious injury ifthe mllaneroc. ere ta rect, Srey tm ecevedcomphls Usk perfor hal ycared wth th ul mo nec srg seco ‘eélogepiily ode cf Ue Pepa. Tubs bs atonal cay INR: ant ware date 1601. 00UD: pete 2 ESCs ved devise wk tain be aoa, ‘The mier-ssee was wane date acento 2 (GDI cient 1605:2016, some dae 1608-202 Povcaons Ln sure woe ploedr cine 2310 pation i asynnomae ime ain hep erty, MMIII ctear ane 2112190 nwse date 1:2: 2610 Perormtion served ce HSO. Rega pcre ce SUVINLTIBG shows esse & suse aie ese 4 pe ool cy MOI ies date 1-200 se de 1:26:21; Pertti on MEG wes dse obser ia De een evi HORII dest are 01:2C10, oar das :22/000, Parmscm Drei oes side thee a de on 01 IG; na ISG daw E090, Btn vy-upcaate, "singe oe pviod oy £2, 2h Sen 4, 2001 se mete A mp ptt, Toa He Danan oF bel fr srt eva Be te i aR en lone?