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Sen Femveizon Diaict Cae DEPARTHENT OF HEALTH AND MUMANSERVICES FOOD ANG ERIE ADMIIE-RATIOK bere Me Ca vrhy, Ses cna ta Bayer Uke LLC |e haeamereaNrareCT Tn MoCeay Bod i ‘SAY RRSBARE SEP ODE PRONE NUL nH COTE] pls, CA 98058 650° Je2-4o0e Hosice of inspection is hereby given puraunnt fo Gestion TOAlaht) of te Fedral Fora, Drag, swt Cosmeton Aot [2 U8. 34.9" andor Pan For GTI oda Puble Haan Seyice AtlABU SC. 262-284 07 Ba. ‘As anil hsiess that «Motto FEA regalo, You have the sight eaok aswsance fom he US Sal Race Sambisvaton (S64), hl sssirarceincudeaammachan io xctees Me enercomert alone of Pelt ener, 88 as 8 Neloral Srbusswans Offs teat rceues eommerts om smal txhoeape about Fader agency efrcemen acter. f ou ‘sella corurentent sforoamen! acs FOR, GALL (228) 1242947, Ibe wetahesLteese srvobe genio [i hes an Ofc of tis Cuca a en hoy ra busine wth orp fdas enc Attn FDA For Inet infematon, gts wa. ue scinduey, That of ea ca be eared gong (0%) 782 E590 or by ara erin os oe ager ee 12: POR WARES ATT POA Eel — AP 9 Le ‘naib C. Crome, fer gat ‘Aaplsale portions of Seton 704 and ether Sento of te Fodor Footy ORB, Ad Goer fet TN UC. S74) Ane sunbed below Bac. ode’) Por pose of ennemont chia fat afters Cremployees dy deste by te Sesrtay, JpaM rere ag Sper, of ae In cha, eta gure A) te ener ot Feasonasta ita, any facia, semteune or eeablehmert ‘es teed, ugh, doves, kebsone proses, er onwarke ore anufacurad, proceso ached, or hed Frdicon in Ia serene ler sich mipoutton, a a istry ohne bang ueod9 Vangel sec ood ange ovtoae {Bosco order eames inns covet ae (8) ‘o inspect, a eatanble tan within seasoned mM aramonesw fame, cb, wero, aan (raat end portant tainsen ihe cad une Feta, covtiway an bebng thew. tne ese of ay Faison foic.eing fame and tasturais wha menvfecuroe, Drovstots fe Conepats,dtbtoe, hols 2 pare boc, {he Fepooton th moon’ > fracas snd oor infmaten Spprmiate cacertas ards won not ove conan, | ocean saten 416 whens stand cr nacon Unser prance (1) cr) of ect 4a) api, et Tesora eoatangs'n orn 468, he case cay aay wasehos, etablehmest a seulng bmry Wh rescinaan cup. rorgmciptow us feta or farsa Se, wstied does, x tabasco oiuds aw mana [recesses pated, or “oh, pacar shal ered ina ngs (Pern (retaia rca, “is, sper senna ard ‘eee aoarng em wremerpreeroten ge hase on sigs ened" Fumi ue esed dean, chest Proce wot a sar r rites wir Us reer tis ck o° eich ray nat Ge marae, inodoed ne irene cemenrse 500, fied rade “ene ct Sry pevace tts fete baer ora beg menue: Ieoseoed, pasted, “aasodeg, or fwld my Auch ns, {theve beaing ch verona se Ny mgeston aha | by the p-aceang serie rv oy parayarh shal enor #6 ‘herd dol, ses cata ear an amp dy psy Cots, eronrsl di afr on ty as tr gual oe ‘and pefesionalpersea pertnmlng tains mate {wre on Free} FORT ron sit itiy _PREIOUS TRONS OBSOLETE Paget are WOTIGE OF INSPECTION fe, and tesasren see (eer ner deta ‘lang ta raw enige, nth cuge deen, ad eco prosactsand subat TS fepsttag end. iscecten uncs? requlions.Iavly Issued bituaiosecton Sp for) eaten SB, seston £2549, apes ane dat nn te obs chugs dowcos, a bse Bod, wtb 1 ho sage cf a neu dun au bo autfec fo ‘epong or Msc unee ter gules puruant BB eauten 061A seperate note stall given er esc such ean, Lu stat shal nt be regula (or owh ery asde “ithe ae cereal eng Eat ac npn alls coremencad and conplotaa wi easoraiie onpmess. en TOL 2} The pravHlons of “he thie sefonen af psrapaph (1) ol red ply 2 (preci ahi eras Esiaeehmente In contmranoe ach any ep eae Tocl Fouls he prin ef prannscy an rc and wth are Fegulely engaged in dscerirg poecrpen ago of dovces, nor pesetbvens ot rattovareIserees to Bannister Such duns or dens penis ade he co of su racibones Inve cares of he aceeonal proce, end wich 3 nt ther shcugh # subaalny er eration, raruta>-e, proper, ppssanat,corpsund, of oes tgs of daVOme fale thet rant fe guar ooura of tot Ousiase fa epee ring geo ene rela (6) tata ewe oy {Broce wad digs, of posers or ure Bove 35 Ing ease may be, ane ura manu". propare, ponaget, ceempound process zugy 21 merufacha x process dees aly for usa hte cove of halt probesional practow 1, fects hin enol, prepare fropagse, ony. caso arms, cx manufac > rouse dias sul fuse Frrescren, actng.o orn. analy ad nck or at: 10, tuck oar ave of persons a§ Ihe Seer ay by feeaon ‘Samp for the apolesion ef his section poe dey, al inevecich ec ned So mae tte of stan © womans ‘hi saa eno nay Ihe pete te pu reat ee, 704, nh) An niet eam ayee making 90 inspection | Inger paagrart (1 for purpease af enfercng de rau stared 47 apieanie a rier falar anal be prea, st [Lesson tbgs 0 have accrss ao cooy ahd aia ‘esr 1) eeeg on ater feet fermula meneecarad “rh in he nity ape meets WoUhemonle aechen ‘Sori eged tm 3a rarvanedundorecton 42. ‘Sec Fass} Upor craton of ar such rszonion ot ator, ‘tachoust, cvautng lbosiny, or Thee eisbahaert an For eating fo promies, he ofa or empbotoe mina ho Feperion shal geo Pi auner, operator agent charge & "port mn sell fob ay ooo plasious ive tipi Hn this jusgant Ind tate food, aug canc> (Gaoea pro carat nuh ewan) canst Ute orm pat oy Ry, puter decreased aubsnce, of (3 on sted kd det aaah onda ‘shrcbstrar have bose ocnzmipsoe wt th they iting hava Eeon fendered inure te sah. A cap ofeach reponse bo sont wonipy a Po Sosy See. 764. tha ctcereremployee making an such tapecten of Soda, warns, of ear ellivont se :cned Sry somata ho sere off rspation, war retin ie napeatan an pc to lnvg ta promos Ho hal gh luearor raged sage ase dosage 2 726. (6) Whonevor in the couse of ant auth inepscton Evtacery 2 ober eeuvihnent rere fos ls aruleched, Fracestea or oacted, be aos” en cpiame natin) ft Irejctonettane 2 eamele of any suc: fons. ad om anal ‘sade of 0 emis forse pupoes of aecorainng vee Such hee eons fr wie ot Ih fat © amy Nb ecompceosaubstanca ore omerngeontar cay ct te tals of such amas eco Racahed ota fee ‘ane, ero ag 9 eo ‘Sex Tefes Fey pesen nou rn een 619 ce 8209) te aialn ecu and every rowenta charge 2 eu fo aucs reco sta upon request of +” feet or erp eye Uesigteee by the Seceley. pom sud Oc w arrbyee at ti raneonele ‘ran to "avo ence tend to copy and se, Sector 11 (i) Ar saad para daesrkad In pres (Ghar erste coset he ving qunifetons ‘fhe coran su the enploess che person, Fe prosedroe ties ty he Soren tor randingcantdaral momen, "e onmensin: anergererts rode Wy the psn aod be ‘onedtise oad by the pizen ta erly and avd conti of Stars Uren he request fe che 2 enplayee Seterated byte Sonia. te pdeen sho Dts afar cr enters Stal coceeneb eee, hava soos t,t Spy, and 1 vay sapten $22 Qf) Ine ont ot any nan eal 2h rerio Sr aprrial n> sppizatun Sed pnane 9 mason (Bh in ofc tn app non wo eta ei mami euch ror. Sha rake Suen veers 1a Fe Seceany cl asia wing 15 Sirerene, inc.dng epee wilh wes atho-aed riot ‘ubeoaten 2)448),ob8 ote dita ct Inemaben, reese Ssnee siamed of each poplar wih teaped a nud i, wit oepect oan feeds bag or eoarng suc: 379 ‘2 tna Seactey may by ganorl guaion or W oF" lt recocet = nich oppor eset nt Bou oF 9 fing {Peceuch cere arc verona necessary in fds toenatlo he Seoeiny te otra, crake s teminaton, whaler here Sormray be grove fo “wstrg wheecbon eer aabxecon fl (Gy et hie eaten. Suth esuatcn cr order chat prado, ete fhe Scetcary seems te aegeeplig, lor the enero, {par requne ye porns fo whom suc rea er rare Sopleakie, ot sar oman rested ur uerice ube Byte Seca, (2) ery sess vied ure hae seen te mana raoarde, ara every peed n hago or cushy ares sha Upot oqueat2t an other ot employee deat sta by te Sect ari such fies or snplayes at ll easonale tas neve Souaseta an copy and wey cuch acs “Appicsie accion of Parte F and Got Te I Pube eatin Servite Act 42 USC, 202288] ao qutid below Par F~ Uoensing~ Biologia Produce and caret Upteeaane za? Sex 251 Avy eter. ager. oF employs te Depart ot Faith and Homa Screen sur! hy the Betray forthe Fufpeae sy dung al raechese Rote ne 2 ee ony Puaiterentor the posgation or ranlanue avd rrepaaien (Contr en Page FaRarbAa7 foi) PRCVOUSEDT NTS GHEOLE TS Pega oe iRemae Faas) NOTICEOF NSPECTION of cry virus serum, taxis_aniain, vscine, Hood, load Durponent Gt deinaive. alaganic podictor ear poe! Srvaid rele, sata" crexsnoge te Dinktof Cumbia, fro be eat, tego tenuate em any Stee orpoesacalan, io sry ctr Sito possaason ory argh emit. ‘for any frag coanty feo any Sa of passes" Pater 13 seek Raton. $300, 990 A)“ the Secretary fn er geod eats 1° Ho | “paode, of Noga eet oelosreie soca ei Sato & pavialr laclom, weeaoun, or ees5- nonlin ‘ren eactora prac a4 arelotied he, tay 21 Be ‘equet cr asia, Oizte >a aoyeae 3.3 designe: byte Seer, wan prosaring separate ede ard 2 wlan otce to he vier, ooerle, r aget © carga am Hisar Sudvoeod (fo ano, et reesvatle Was dry ate facon, warence. a esate ohh Bomar er tees lr tasting programs? reacted by socten S58) ste cre to, rd} finepacew-reaponsble Be and wh eseonaD is ana n¢teasarble manner, he facie and proseres ‘tin such aoa sicher nclec elected roeten {aby Each euch nach al bo common snd completed 2h eaeenabl promotes. 11 aan so 2h found pen verb gone eause may be fours purpedes of Ns asain, 003 daiae wil bs canskorad to eat ney ame whe fe FronufctuarF38 dua Io tarmac ay leon prea. ‘then dna eon ith a. eepeble stead preseied Urcor hssubpar end ware wie re nempaon fm tie nolaten reiemerte hae bean granted by he Seer, user acto 250642} SBR @) "Try manufacturer =f ekeenle souls shat fomablgh ra risa such veces (nla teen reco, Fake ach apo and pei such fiom x ha Seat "ay reasonably rere ts enatie "tn ta dete ie wher ch tar tc is eed or seta In earoice ns separ tne slandorde proceibad puresan {0 Dis sapoott are shal then equeat can aor ot ample duly digas Sorat, porn ch offeror employee to ere! porate backs, pepare rood eed documents ralvant to dear whether uch menulacuer hss add orb ecg m orelance “th etandecepresrbed punt section 2551" Ths Secretary may by rate wate dont and “saumitors ef electric pros, i which tere ere spp SSancbede croosoed Unest HE sul xid relel rios ‘hunah tenet en than $50 fe fra masfeahee of tach ross. such ifemnton at iy be neceseany t ide Bhs este, fe fupooos 0 secon 969 the fet purtatare Bion prodiek fr pinaten cher tas esae ard (2) re mantfecures fb prose uch ‘uachn Any sln Swab srqurenen:pesiont caae 1) of he grein Series sral (A? rubs sich deshte and dbutcrs te Beck in Su of iereatcy @ithing suet vometan tthe Fora’ i hele sae ese uch fat tb anvieee 2 tw rani oF Surety Pat Such ifmation le msec by the ranuetrer fr purpaane of eaton 986, an (8) poe Aha the dealer Ualibuor anal, Wit ekg uch schon, i prompt nates cf uct elecon (gee ih ramets ‘Deroy Tha webs apc tho predic} tote onutare 2d Sil nena by ta mane Sacra, of he med Thectre for he purpoves of Sacto 568, mesg Samah Ne rafter ih i reaured erat fy dele or ter ‘teczrinusa th dosing In er dir ton of lasers grediem hie shat tan te INentaien over fo the menace Ay Pmanufctrr easing nfrmalin pursuant oh suse anesrnag tet auetarare of procuze fo} poses ater thn fesoi so Lea to ordontal ne na une only necaeary fart ps pote nang pereensoumvart ta ston 35H)" ‘2.859511 aa se. iied ers {EP ‘or any person te fl or co rehie to estblch or usin cords recites by the evar or ta carr aco Bp Ihe Secretary oor 6" he duly aude wpraarttves "0 1 ne coping Ui oso, eta ary cr epetan, B ‘pau orpureyat-t ean SEA" Part. Quarantine ara nspaston ‘Ste. 56s} "The Burger Cenatal wth the approval oft ‘Seeiiny, fe authonasd ta rahe and enor euch oul fn Ni rant tre nesaessy a preert the ‘nko, ‘fansnision, oF spout ear reabi Geaaoee fon fl ‘turin tate Slaes of portation, ce on ort Sal ot Freeaca Rio ony he" State ov porsee Sn, Far ples 4 coming 24 ant ening euch reguets, the ‘Surgon Gere may prove fr euch Suge, una, dt, Santon, ose! acsrnbaben, dastuctan oh artes oF ences Taunt ba #0 inisonc oF ontamivated ae ob tarot sdomaerois Ifa To human De geen Oe "nase, Ii judgment maybe noacesan™ FORMMDA 482 (841) PRFVIGUS EDT ION OBSOLETE Pagesets WOTIGE OF miaPEETION se Isaacnsp Dari Ofte TEL Hater Paco Alameda, Ca sisbe (0,334 st00 DEPARTMENT OF HEALTH AND HUMAN SERVICES 'FOUG ANU DRUG ADMIRISTRATION rc Sor Do pn Ti Sus Nau : 9 mentee 0c a 123%, "i MEER AND STREET - z| 7 OMT Barca Fed i, CA 85005 *! an. iSseyoonaetes 1k) of the Fedral Food, Grog, apd-Coameties Act 3 Us. a74(a” snuior Par For 5, Ths i of the Fue Heath Service Act BE U.6.. 282264 Re a anal nusiss th ls auboc 12 FDA equa, ¥2u ha Ba (ge eek aastlanee fom he U8 Small Bxiiess | Adm nator Si Ios aiectnce clase amestaicn iowa onbearant stone of ede geraen SEA tes 1 Netons Omoutemans Ofte thet ecalvescormwris 2 si bustesee abut "ears agency soeamet atic. yor | wise commant onthe enereenent aeons c! FDA. CALE (a8) 7240247 The wad eaton sts abe overdo DA hasan Df ths Cneudu ta em rectly ast smal tures hea PaIEr epee thou acon the +A | porns armen 30 saree scvotaduny That aes can ne ached by calling (3D) TBOASS0 & by east crbadeoe ego ios Eesha — RP TNR FAN WALES) ROA Enea Chu iota ©. Gree, Teidaabe eis. Abraza nei *Appiatia pemtions of Beton 704 and afer Sect ofthe | Fedora Fool, Dvsg, wba Coometc Act [0 Ua Sra) ae | ‘hotel bolo ‘Seis roa! For puessa of anfeerert 3A, fiers or ereiajece diy dost ty the Seca. po posers Seoepret cedars ord € wets nas fe Mee, coor, or agent In chnge, om aut-esond A) Darter at | ‘avarable nes, ary faa, werenouse, of stablatant 2 | ‘wich fos. stags, deta steers pred, or onarates a | Panwrare, recone, peck, of Pal, ft ridin me iterate cor tee err sc nod, oF 4 era” ar | Shi Hsing uses io wanapart chaz suey fod cane, devine, | | chose produ, ar examedce i ness cattmaree 2nd (3) 4 fo ntpect a ostcnabk thee snd vain rcesonale eed Fis veasote’cra'nay, wich cob. warehouse ate ren, shies ae all prinem equipment Misr: are unned Frelarae, cunkiners, ane lasing trace be 2 6 ny person (oaucirg fame are ersurers ue menus, broceeoes, phe, Nap, lato, hal, oe bmzera fos (03 eepecion shal eran al reetcs ant oer normaton ‘stot neocon, hen he sland arse inspcton nde esata) 0: of ecaor te) apn abla she iar adh noc 4), nt ae of fay, Uirareisa ecetinhrort br soning itary NS rescreior curs, nonsesealan age itt! or hue tne, rested dees, tesa pesado. Teruo, preoesed, pated, a hey, epost shall dee foal Cree then (notcng rears ba spare, posers, cle $e Faces, boom cn wrath eeegtn ahge nensesg efor sige reid “or Turan boo. reba’ can, or Mbece® ste viet a silt gr racanded xine reatng tie et er wich ey vate man ache, cd inkesine commerce, 2 80. or tarot Be a by roe fry puson of 8 Ac, eve feet ee song manure, ected, pases, Penople or vel In ay eA" par, oF lense beara en vat of tha Ad. he Fapetan nibs by te precede soriroy of 3p peasaph shal ener © ‘ardal usta, anes dla ater Har eafmunt ia, preg a, pasonral date (ster ciot cla os © Mulls et acne fd pretessanal personne: pertarlng tines subi ate {anevcd on Retest FOR FGa doz anniy PREVIOUS FSTON IS OBSCIETE Paget NOTICE OF RSPECTION ‘eg, ad vena car fear than debs rela an ue, Srabate dage, devoce, ard tauaten pravel ard hie! "eporiny. are inspection uncer realsine.lavtly Teed Besvant in secon 608} of, secion SYS, aseton 820%), of hapten ere dts “tans U3 te rus, cove, or eb | Fotos, ohio in Ue camo cf anew din woud aubect fesoring or negate unr vl atin teed eh tamer BOSf)h & operat eal shel be aha" eath auch inscton, beta ote abel ote requrad teach ery “de vig pared devsred byte rspesdon, Each such ispecton shal be comuenos¢ ad comp eind wih easerabl premio, See. 706 (ai) Tre preuions of te tind cantare of "search (1 sal not aly ofa) sharmacia van en Getbianmania oucfo"neroe sy ay syle, Cel ans Iaguleng he prsstce of phoma ard moda ans vive oe “taunts sromed in depersie presxpuen drugs ov dees, Zpen prseigrene c?preationers eae fo eerie sch huge or dovias potirs uncer fe care of sh practionra inthe ceuee ef for profeatons! vaca, sa wha co ve fer sgh subaity or aati menace, me Floss corbos"d, 0 oumss cae a” dole fr eds at ftanm ho roger cures o” eb ciese 2 eepelna or | belng ous 2" dvles al tal, 6} patos om"zad by lt | 1s presate ex cir drugs or taec"ba or uen det, 25 bia cate Pay ba, 2nd wre manode, pre, propia ‘ervoure ot prossee dues, or ramuocure cr prose devon ‘obly for use tho caus of bl prota! pros, pesore who manufac. Diepare, eropagas, carpauns, of ‘roses dhiga, = mancecute or pacors doves sla Sa" ae in vaaaten, asning, ei cham cals one nel Ol fh rer dees offercone ase Surely may = rogue ‘Stenpt om te sonterton ot bla sein fen hang, Wet hapeaton AFB le such Gamer of pees s0cnse Nee sh ts econ Is raeaary ft fotacon of he ble pean Bec 704 (64) An fos or amplyoe makag an iazectos “der peragrapi i) fr pyc ten We wi een ‘con 482 apotcala> rant ls sal se pera, at Sreodondda ne av case Leh opr we wey Tecents (A) beara en hehe the keer farmue revues Or ald ithe fay nspotad rea a reqirenets a Secor ig. or (Bt raasted the raat irdorsdtan 42, ‘See TOE) Uo wean of an such inmpostion cf fac, ‘eerchouse, contig lbertry. cr ute esteabtmers, ere por's eavng tre penises, ie fizer er mtg ing Po Frspecion shal ave te tha seer eperes, = ager: ena © raportin vag at rg orn ay chats proces mrves fap wai I itamor not tay fod, 2p, ev, ‘enon: prod, Seer auch ecebieinent (1) ota ‘cls eri pata ry iy, Pn or decomposes edbsoneo. OF (@hhes beer prepares, pacez, oral uncar anh ardent ‘Wharey tinay have Beare cantante wn iyo hee We aie ter ered roy mech A oy OF le” ‘norshal be ean prar py tse Sec Se. 706 ne emcee rskng ary such ispernn Of faci), warehouse, of cbr enslahiant hes oped Sry sampla 0 ie callan& re Feaecnn, inom compat ‘he spect aid por lsav.ng a ramisee hs aha. gh © the On eprata, br apert in charge woe ese ang he ‘np aba 880 704, (a Yerover nth coues of any suo nspzston fe fety br oer seize wha feo Te maracas Procatiod o° pedied, efter er amgloyee moka he Aopen sre » exis any sph foc, an Beale is made of such earl fre purpeca of acceralng water uch ‘teg eorauta In hol ath Bet of a MINA. it fr desorgceed artes @ cher ant rood ny tho foals of such anos shal bo rind prey Ue te ‘mer, perso, apent henge. See, 704(s} Every portan rules uraet sedi FYB of S20 le win esa and ex's Foren ni in here ory of sich records Fell upon rogues ol ex dens or employer Seclgrated ty the Seca, poi auch nice ne employes et Sh seavenaie Hines fo hiv acoces te ane cnpy ad ety, eh reccede Sect 704 (1) Ar acres parton caserbed In pary-an ‘shar anal reooue dazumersng the estng auoifetors [Fike penn and Ue expojzee of he parcn, Pe frocaduoe dsd_ by te person for fancing endorsers, the Garpencaten ‘etragemerie nase Ly the serena the prosedmes ned By the Paro fo Herty and svaw cate Inierst Uren ths rocuoe ca oftce or emaloyee doignatas Dye Sacietay te person sl ptr to oer er seen St al ronsenabe mes. to have acoso, cy, an Ye Seaton 12 (1 Ina 2am of ary naw Saat Pt uleh sr sen af se splet ted pus fo subsedoy fe in ott the apt crt chal etalon and’ malfalne:2> ass, fra’ miake such report Semen a fain tkting fe epee neue expec Win e50 guoNged ureer fubeeciow (e}f(Q), ana abr corral. teed or ‘Sheprise obtains oy sua expcat ai vexact te "oh ug brut respec: aneal fs bear oer suhag {me Senetay may 2y gator fez, hy er th ‘capes fo such appensen frost. on the bass che ting {het su eons ars mor re netasarym rd to ena he Stein azine oe re determina, wether re foray he gine fr iver subscten fa) auRees (i) (a) et eachon. Sutn rogslaicn er ard sl pout, hare fhe Seem) oes I 6 be apron, Re fe sxarineon, ncn ruse Ey me porcanata wher sh asubon ert Speleabe, ct scar Women recs’ o- obarwee oaned tyke Sasean. {2 Fy sero ror unde thie sues to atin recur, na o¥eypoechin charge: satay tert eal en feques af en oficor or amy designe’ by ths SADA, barr cuch offer cr erileye at al feaeenabis thes to howe ee loon cy and eee a *applleableseetfons of Pars Fare Gof Tt Public Heth ‘Service Aet(42 US. 262288 ar ated Dee Pont tant ~ Blea! Prose ad Clic UGttorioiee st" Seo, 351) nv fxr, agen, of empleo ts Daparivent Hein and Human Servos, chard bythe Sra for ns Pupasn,rgy eng 2 reaorabi hore ne and eoac ny Satablichment er tha popapeten af menutocura and prepara "Cendnasetc0 Page 3} Fonm Fon aizfan) _ >REVIOUSEUITION TS UBSUL=IE Page zarS Rares arPagey NOTICE OF WEPECTION of ary ius. soum, tem, entonn, caccre, Hood, blo unathent or detvatve. sfergene oduct. ar cher presec, ‘frend ore barwe of aschanga lie Bitch Cour, rt be ser cared, of tought fom any Sua o poses Io ty oe Stato posaaesi: onan erage uy fram ay tei coumey i any Suter poseese Por Ra*°*4*-Contel of Ration eq, 0 A 0)" th Secrlay ‘nde fo" good cause tat Ie ‘etnde, es, of progam rakoc beeches pou rat Sets a partly varehavee, ar exabeent wich tecture prac ate manure er Fld trey mr be aunts or lab, oars 2 epijews oul Caagrae oy ho ecceby, open presenting spoons eecaniae and @ ven ret fe cunt, pers or gant i enarge, ate cro: suthoreed {1} 1 vie, at reese meray ea uch factory wartrowc, orsseblahrert wind he manacurr teas (or testiog prorat) requ by ooran 31 ct ul ad 2 to spect a eaeseble dimes and win easanabe lms ania esssrabe saner the tcitos sre posenres ‘itin such ates ule es teated 9 aici procul “sot. Each sur napecban hal te can snenced andere ‘al caronebl pramyncss In aston fo abe gros spon ‘fic good eevee ay beta purposes of ths subse, Gone Foto wi be considered (0 ene n any caso vere he apc’ nas ued commen ay clereane ped ich Sues et comply wih an ofperee senda proscioad Under thi eb anew espe wnish Ho examen am tne notfeston regaremerts nae baa granoe by Seca nes” aacon #562) a 35 (2) Every narutacuror ot ekctiene educrs thal fshablbh abd attain auch “ecorde Gen cecing reor) rahe such oars, seteids se nomaton soe See "hay “aasonsly tx oat hit Sete ne whet: sce ‘nenufoger hes ered 2 acing opkanca wth Ot ube fra siaiderda preserbod gurwuart tthe espa and sal, oon rogues ef an fo or erciyee oul eeegrated ty fe Souretan, pan sul oer 2" arrloyes 1 repoet cere books, paper, resort, and aocemana erat I> deer rete nuch tartare nae eed or ale com ons ‘seh stand prescibed pau a anon Soa) {The Sect may hy ata (1) weuire dees ant feb of eesturke odci, tau tere ara setesie inde protein ths sibpart are vec snot of whic eal as than S50, to era ane focorra of suc reduce such items ab may be neesairy teeny Sl costa, fr porpocea of Seton a, the et Cucatrs ach Frade for bpases ‘her tran owe ane tule anoladures % presse such ‘oman Any iegusios ‘tabling a equitorert prsiatts davse (1) ote werneg Serie shall () autem tue sears ad bee (00, tof erecta furshirg tic internode tthe Ieruteire ofa ae pager such lpr ul aoe bythe manuf or Seca a uch mfymaton went bye manutctrr fer puosees*eacnyS06" an) rove ‘at re dealer 6° AM.or shal, wan making ouch eecion, B86 prompt ola of euenteton Ugeer ah Rosman ‘dentin tho ner ad the sat the manufac” se {Palen oaveed by maratgoat cr Bnet. ow red ‘harsfore fe the pupusa of Seton S69, maces tums he ‘lan acter wm refuted Ratan. 12 eae dots fteconanuoe te desing #1 Cahn of sechon: predic, he sell ure the Informatica to thant ry Ienufzcureroneehing israton puauart tr Woe eutecsoe senoeing “rat puraaen of prod:ch for purpeane ner thet ‘esol hal ate covert! ne ray une tote noses forthe purpose e rein pereona pure ont fo salen Satay Ses, 380 8,0) Rebs Be iwi ies £2) te any pono te tel ot 10 ote to aah tain rear ear! By ts scant lo eed exne he Eatery oF ary of Fs ely a sonant precast ‘a cooyng of aa rece, pra eri epeeon se tui or prsant cis SDA" Pen 6 -Guotatae sr nepeion See sbMal “Tas Sugson Genel wi 8 cepa ot he Bee'iane 6 autorzed te we and enor aust eqns ‘2.1 is judgment ate spoanary (9 sree the nedcon, Vavsitsion, or seead otear mrisain eseee fam test lance int the Sates o pestesscne, or fom ee Sete oseeeron into any ther Slate or zonasun For ponoase of carpi aut and entecng such eguetane, the Sergent Sereal my onaice fr sien maze, Emgation clanseaion sanfatn, pest ments, deatustin of rime ties ‘une 10 be oo Vested or ontaineted as to he aout igrois mcion te Purtan beng, and kc’ mosses, a IN sgre-tmay be “eaeany “ORW FOR az [87) PREVIOUS EBTION IS OBSOLETE Pagesars NOTICE OF NEFESTON DEPARTMENT OF HEALTH AND RUMAN SERVICES. FOOD AND RUG ADMINISTTTION im egrsose Duster Pe 8! Natura; Pacey Alameda, CA Si sid otSsten params saz Drcector lion GC Rahact Me Cacthy, Se Beyer elieare 1 Ie NOpSEe aE SREET Pion Mecanky Bled ios tates, ca 9595 PRONE W ERA _ GF aFr62-41 6S Nottce of tnepecion be hereby given puruard fo Section 7 US. ara}! ander Par F of G, Tle I of me Publ Healt Service Ae [42ULS.C. 262204 ai oF thm Federal Foon, Ovug, and Conte Ant I adroit S18) This esetance nc Lec atcha Sone Gnbuesmer'® Ofte ht rocevee cana a al fabio ezranenton in aroreamert ears @° FDA, GAL 8) "Taig canbe woacted ev chy (301) 74-8829 or ay ana [Forint eterna so tov grt. {Ae small cumrces Wat aitjua ta FDA raglion you have Fw sgh a seek mexico Fan ha US ral Boanawe FDA hes on Ua ate Cirtenan Yates? aecty ait eal burineae wh corps ts or dputee seo ection ce FS, ies the astro" cars 2" sera apenas, SBA fae = ll busnesres bout rade al agancyenerewtnt sone, od 734-5287 Te webu ate ew sha gover ani anton Gor ag. ESTEE Te pan Ema ‘Tinh C, Sreme, Inecdguc, “Applicable partons of Saction 784 and ote Bectiona uf tie | Fedorat Foot, Brg, md Counce eh [21 UE Se) se fuoted olen: ‘Se, rosal) Fe pupoaae of enorme of tie A, ficete 7 glopee oy Coe ete? 2) the Gemstar, Upon ase cohimpisie crests area whieh rece he ewer ‘perme, o agent Wn share, vo autkorzed (8) le erie, at ‘sonable tes, any faery, wevenouso, o etek ant wrk fo rugs dawns, fobaceo Ronit. cr costes are Manuiacras pressed, paces of Ved fr focus ID Incas commerce or er veh Ios, of Io er a vette ting set renepr er bl su ood, dre, ae, Ithaero predic, cr cameos 1 renee cera ane (5) ‘oinneech, at easonabe tree and win reenable j a reaconabo manner exe folory, warchousa ett tre Gr vote ard at pertinent equperény Rshed ae avs vei, carta, an “abOInE thei. Inthe ase ota | pereen (ocung ferns and rosturons) ohs manufactures, Procesoss pct, waren, aie, oo, riers fo, tha apacton sal anes to all rcora ant cher hfermaoy > ‘bcc m ater 6, what bo elas fy eco pace inde steph (er) of eskor aa) apn, eject oe Instore eta eecn ag ner nee of ey tty, weehoues, eakbinart er coming” Wenn Weis Brescien hays rongrsctpan cre Mme. bomen the, rvied doce ‘of aberco pre ae ranecarad brosstee, pacea ebay, apaien tat prone sl ess Bagh (neti recs te, pacar, poceses, cn end faces) beara or wether Erecrubon ee, crema yn tugs itndod for furan une, "etoiddevien er Wtaese Fade fic ae seed or marae hn a ro, (hivs Ack ox whi ray to! bo ma uated, hese fnorcse commen otk or ofa hy cao by tson ‘Sy posi of ho Act howe lee or arm barg aca, (Rosato, pacied Lareptd, al Ih any sh oon oF {etn inaten vit ot M5 Axo hase Arse by Be proud setfovo aby raga 2) shh ean te ‘ancol det ee ta ate Do pear de, big oes power aa (ot ton de aa 2 eudteaos of ae Gnd potesionalparaonas: petri hnaterm sublatto e {Coneuedon Rowe} PORWR EEA) “PREVIOUS FUTON 6 OUEDLETE NOTICE GF INSPECTION Page ToS ‘et, se acerca mer thn dat eating to ow dey, alti cms, cites, ant tao roca bed ieee Te feparag ev inspector uncke resuatons. wily att aroun sat 50 7 rf) seen S19, ston S209) oF Shatter aod cas vlan te ater age, danse, er ohacc0 ‘dude, when me eave of =n ctu would Be sie feooiy of hast onda regulon eed pur {p racon SOSH), A sopart. nabs sl beled fr atch ach ecient re or ach erty mat uring to pon oiporad y renspec=n sth zh nspocton Slo comuenood and compli reascnabk erampiness 500, 74 (ofa) Tre provers of the tins santo. of paragraph (0 ell not aly to ()phanvacieswhien rane ESttehnerts hconfomarea ch any appt focal las Faulting hr tee of pronaty and meane as MAS aro Fequlet)srgeged in rlsporsrg pescrion A nr nds, Up pins or pre oa lesnees te aSPanster auch ug or datos pets Unde ha care of sch prac ones nite coves of har praised race, avd w°48 3 nt, titer frgh a subaaty oF SFentae, MOnUacUre,aepere, roantiecorvound crooner vate desi a et (ian ie rater cures of thar mses of eeponing faling dre cr devin steal (8) pracMane'stomeed 2) Ie prescte o aarinstar Zug,” resoibe or uss ces, 25 te eee may bs ard who manufrs, precae, repegse, Earpound, or ros ig, or moutsesre posers seve Seley for use n fe oa of ut Frcfassonel pret £0) Parone in mavelfe, pltare. propagate, cemaura. Poosae dupe, or eandfacve or proven desea any“ va frgeesich, faateg ef chomieal ane nd not Ease) uth che lees alps us Ie Seren may by Fogle ‘barnpt fon to apoeten of wecon oper # fuding Ue 2» opted to euch cleaeae of pateons 1 azoriano| oni tacos far he lee oe pub ‘See, TOC {9} An Seer oF enplses maktg an nepacton pargreph (1) fr purpose of enforcing the manors. teaoton 40 appetite rar fomula al ze por tad at ‘teasers ‘nee, hme aecee 9 ar to onpy an wey on ‘oars l beatg on What ho Hn: frie menuiscbiet Ur fald inthe fy speed setae meguemerie a Sesion i210" (urocuor inka maltinad dor scton 417 ‘Se 702) pan ape af ary such reonshn of foto, vesehouse, cou Sborory, ef ches enestarner, et Flr cava ta grees, fe fier x cnn mating a inepecor eel ete-0:"% oumer, cba er agent Ir char 2 raporls wing eting oe ary corte or practices carved boven, ne ioe, nest tn ed, dup, di, tencon prot of drat such esextat (1) ons (leer hat ayy. cutie or car md sublc®. (hn bos eased packed er old da ani eames ‘sheraby ray fave bacome cornnies wh iy of he ey {iy hava Geer ranae-edpwious beak. A Spy of Suc ‘par shall ert unio Sete, ‘See. 724 (§ Ite foe or erapovos maki ay sac npecton chat (lay, wuneeuse, ot ober aeabushrant hes cbned Sry sonpk inh ccugh of Fraperten, wpon competent the igen prt agg ho peemce 3 hal NO [ep onnss opemiee mr ago menage “ooops deco He sarvlas cared, ‘See. 702, (vena ne era at any auch Iapecon of f facry oF cher season there foodie Mi ae procetoed, or pecked, ra afar or ongroyce mabing te FReperinr oats @ sample «any ssh fs, ae an ana}el in made of eh some fo se: arpa 3f mecoaneg hor Guy tod cones mn wnala or fart of ary Aly. put, fr comnmpseed aubntem ia shettse unt od 6 py of the osuln of such alps eval Somes” pom fo ne ene, erate," aca chee Se. TEA(e; Even perso” rosie undar vosin 819 e $200} fg nan reuse ard ey garsn whe ih erage east) such rcords shal gon request of ar_amcer er onrloyee ‘tsignted bythe Gotta, pent sue oficor or emplves st Spee Sree Cama oan py ey Secon 704 (91) An ected parse seacrbas i paayrape 2B shal maintain resarde oamantng te fea Qual estone he pmnon snd we aloyee ct fe peeon he proeedat * teed ty tbe ison fr hanes inray, ie | eonpertetin “ataryemante rade fy ho. pert, adhe roveduer ve by we person tides and ail cont of fers. Up he rcuast of an Tow cr emptiae celanalee lire Secretar tha paror fal pam tis afer or amps, ft ef romgonat ye, ae 20z0e lyf cp, a al the cords, Secten 512 M1) Inte soe of ary se: arial vs fo we anapieovs ovat appt fad gucuart te sibeccton Be inet, the oppo srl esis an asin Bush ects fra macs aush esau lo fe Soar. of dete relia Ie Siponence, Hehsng axtaroncs win ines aumitsd undar ibsarton (o)A0), are shar aot oF Inmate, tected a ‘range cbtaned by auch apart wih rescet to sh dru, fron weped! te ental age Errg or cong eubh dra fa the Eooe'ny mop hy gure fulton, oy okt wth Fespect i aus eppcaton, prescribe onthe beet of « fina {Hat eich rebards ap repute are neces’ ™ caso Babe he ‘Stereo te deeming oie a determinate, wether sare iso migy be greund fr imking eabeacior ao aubeac>a (mj late the anrton, Sn egubson ov erter she Fra, tere Ihe Secreary Seams #0 sppreniate, fr the eran, {en raves By Be petzavato har euch gua or arr 6 pales, of emis: tfomaton tceted or carve ct tite Seomony (2) Every peor 9rd endo ‘ia steacton te maitsin rovore, ant aver) pes haze rcs teat shal Upon Faaueet a" an ateor or aiporee designs by ho Satay, orn such aloe vopjen sta easeable Uae > nave ‘Saco and ove and viisch recor, *Anpllable sections of Pats F std G of Tie Pb: Ht ‘Service Al (42 US.0, 207204] are quoted below Pat F —Cosnsing — Aa Feoduck ane Cra (errs argo ae. S81 Any ofr spent or ample ofthe Daparine:t ct Feh ant Hunan Seroes, uaruad Eye sac Yara pups, may dang a reasonabe Hears nts arc ier ay ‘slblatneet a propagaton of shuts we peperciot (Cantinad on Page 3 FORMEDA Adz ind) PREVIOUS HOLTON TS OB30_EIE Panel fives oope } —HOTOE OF inepreTION of ary inn serum, fox, saliwn, vaca tose, boas Snporsot or dorvadks, siemrie scdus, o ater provuct Sirens oS oro > acherge nine Sstactot aura, Barb oe sont sated, ct aught tom acy Sab o poaesech fre ony ele Sat > ocean or ike ay orig oun, oF for sy foe ceuy np sy Slate 5 possess. amr" Geml ef Rac, See. 900 (a) tha Secotry fo for good cause tot ho atid, eo programe re aled fo obsran pecan Sabin © porculer fay, werahovso, cr eabsebor in Sich clpdronie sreeuete mt mynneied a ROE ay ok Ba Edequate orate of or anoyaoe dy designe hy te Secretary, upon preserng arpcpiefe rece and swtian oive ate owes opener a aortin charge, ee Meresat Sutton (1) the at aeaonaba tea Er aoe s3ch ‘cory, wavehcina 9 scahiennnat ie foe anaes {wes forts coprame) oats by eatin Sh ae cae Du ad C2 fe ngpeck = resorarle fre at tn reese Fens nd in sonable mance the ‘cles ans procecures tit such ace char ed eee poe rae Stn Each auct rspsclonchallbe corral aul wa end ‘it eset jwarploee In ection fo aot gzunde Un Uihion good ease ray be ound cr purpones trae ton, {end caine vil br caneload to ove any tage where tho anu eviodus Fes caneneree ory te sdb ‘when dose na comply whan apaforle slander passa Under sot at wi expe to eh no exercion om ra nerenan requires hoe baer goby tho S26 Under ston S280} or S53): fy) "Cesgy nanufecuer of etcrane prada stall cembleh er man si. roars Geka (og oer) ike sid apo, eel proms sur woTeler 96 e Sezreta} tray rene #ey “equa m onesie Hf ceteris such Frerutacuer hee ated ars nang neompleroe ath We sepa td sandacs pescbes psuant fo hig subse ere She Span sayct of an ala: or erloyee duly design by the Steam peth sudraf og w eaployeeta epee aap boora, pape, record, and dosumets relevent fa delet ‘vee? Buch tnarachaer hapa cre cing In sorplorca (wih standart reseed pursant sein 35518)" {The Secon my by reptan (eave dele 2 cinvinare of eaenn prada, to whi Here ara eros Sandarde precited unser “ve sibpat Son etroteze man $80 fe mean ‘he ea es acturers of ch radios auch ‘nermaen as may be necassany to ion Et lca tr puponen of ae0t07 39 he tat pacar cf ich grodua fr pipases ofr Man rea, and O) ee hnanuscures w fraser sich inferman Ary reguior ‘enbiaiog 2 reqatomontpuuant ta dates (1) a be paced erence ell i) rire sey cer Arse ‘oe, fu of eect uanirg tuck erate IRanufacor fe ot and prgere such infermation url ao a Dye tanuisccar or Seat Hat wh ation eed btn Panter” oumposen of sein 5A, ans (8) Brae fate dele of deur shat por. rar euch ston Sie provet nile of son secon, Gagoher iy noanets: Idorgrg the reir sv tre pod the cn ected {Sal een seveed bythe mand ecure oF See’, ere nd Iharofore fr fo pues of Scion 353, ne Rate Imancietor wits roquod "ort Ire Soa or abot Gieealines the call alton or elenteche pre, he anet tum ta infotnaor over to ive "enact B0y Irnvacur’ race'ving. Clara murine C3 tie aubsecten nearing fat putin of products or purcsce ober Yan esol hl eat tsa conisenpl end may tac ony freseaser) fer be supose «noting percns pursvertosccien Sea," she 26 Beh tl nese fee sor aoy oun to oct ste ox sian ine a oye wigan es peeae Ea cetny or an oa aya cranes to fe aapng oa catia oo ph ay geste Parts Geert and trapetion Sec Sb) “The Sugean Genera wen te sepreve of te Soeratar i suharie rie and enoros uch “atone fein Nn Hgment ee neoreeey ta prvert he Waeduete, ansnicton, ox speed of corr ticala desates For Krvis ‘ulti no th States or poeeadona, or ft” one State or usteeion inks ey er Sale er power. 7 pupotes BY camieg ut end onfoety even regultana. “re Sugece (Goreral mae rote osu tevecon fate, dae, antairpest serratn, dae’etor ef erin ara found tp bo to invade Gotonsaee at fe he ances at Sangerou ifs fo hunan bing, sri fer researc, ab Fis uteri my Dene Fomw Poa aBz Gi) PREVIOUS EDITION Foneo1 Te” Papeaets NOTICE OF INSPECTION Fer Peme sg Digier? OFT. 0 DEPARTMENT OF HEALTH ANDHUMANERVICES | 24°34 “Hie be Be Roc den ow FOOD AND RUG ADMIT Prometeled S545 7840 329-6709 DK eh Crome Fo dee 4 CEO Pan 40,267 8 fel emcee tvs Mae oe i Bet Eve ben Avueut 7 pn. norvamameenr coe ron we RRR Co Poti Youw, ef 24eus Foe Aag tere Mallee af inapection Is hereby given pursuant to Section 704ta)(1) of tha Federal/Food, Drug, and Cosmaticn Acti2t US.0, 974{a)|' andlor Par F OF, Titi ll ofthe Publle Hesith Service Act [2 U.S.C, 262.204)" ‘mil buanese tha If sLbjed to FDA regulation, you have the righ fo seek asistarce “ol Uwe US, Sra Bushes ‘Adminidrston (SBA), This sasktanes incldea a machoren te aaeress Pe enforeaménsctona of Federal agonice BEA ite a National Gmbuderia's Okie cele commont fam emall busipesses about Pednal agency enorme acona Jou ‘ssh la vamment onthe arforsenie prions t Fh, CLL 208) T31-S247, The eet se nee Steosguulombude”"an, DA has an Of of he anbudkman thatcan racy aac rol b snes wth compe or epics abou atone ofthe | UA Thatefce cans rachasLcaling 304) 780-690 ory eal al unloads afore For Inuty infrma er goo argon oN REA Fom a ag omnia Enicnatiy [a WREGR in WiNERTAID TH Rh oom nae % Mon Ta othy ©: Ge | * applcae patinne of Sosion 7h and other Saclons of tha deearbed in ection 414, ea the andar fermoatds epcton Federal Ford, Drug, and Cosmetic Act{21 US. 774] requeted : cater parsgreph (10 (2chsecicn 474.2) apple el he alow Tiniavens astatsheincecton £14 rte ane ef ay ey warePcuse, esiblatrment ar cong Itorsany in ich ‘Sec. TOs} For purposes ot enioremont of tia Act aftcera | greseplon drug, nonpracepton uns inlandod for hurt orempboyses cul delgnated bythe Sect, upon prasentng | Use, reacted devises, or tacacca pelts ate manicured, sopropriata credortole svd austen noi to the onrer, | posaased, paked, ce sec, napacton skal eters tae blngh termi, or agcet In chargs, se aumoilze (2) to ory, a | theron Oncudng rece, is, paper, prectsars contol a3¢ reasonable fines, any factory, wa'shouse, ezabisfano in | fais) bear ov wheter presareron ctegs, nonprscrpion (hr Toud. 43s aeviees, bbsceo procud, er vues ave | chugs intended far human isa wsticed oevces, wr taney, Innutactted yioceseed scked of ald, fr Iinracon ino | pects whi aro 2: Harstes fs misoraded wt ine caring inertia rome” ot aR euch noaueion ct ent any | ofthis Bet or wch may rel be manuaetured. MboAed ie ‘eh bang ise fo anspor er hot su ood. cugs, devon, | Ivica commer, cr sl of otra! for aa by reason of too produes, vi evens infteala commas: and | any prevlion of Iisa, have Been or aa being mantarivd, 15 inspec, sl esuo%aole tines crd widen eaconaal rte ae | yucernee packet wanspated, 3° held it tf euch pls, oF ina reaeenablo manner ach scary warchouse, etaoTehmar: | alheraie bares © wlton oie. Ny icon autores Brveticle and a ostiraxt ectupmert, ished enc anfirher | by the prosidny eovience cr by paragraph (9) shal extend Ib frafanas, consis, end laelrg tein. In the caae ef any | enc dia, vals dla cher thar ehiprien’ aia, pom dst, ‘enon forcing feims avd recede) vino manutecures, | parsannaf dais fme tha” dala ae :o qualfcanene of eral brovewses, packs, anspor, dstibues, olds, ur rr foods, | and grofesslenal peonnsl ofoming Anions subd Is ‘he Inspection shall arto “a all ocanie et athe information (Conte cn rsa) FORM TDA 482 (8/11) PREVIOUS EDI ION IS GBSO_EE Page tof NOVICE OF INSPECTION