fusion iv pharmaceuticals inc. dba axia …fdagov-afda-orgs/...dl:ifjartmiln-t of healttl and...
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Dl:ifJARTMilN-T OF HeALTtl AND HUMIUUU:!RVICES FOO~ANO OR'JG AOI,Qtft:;JfMT1()f~ ,..-
DISTilTCT OJYFJCEAIJCRE$9 ,,NOPHON~ Nu~UIE$1U,s Aogtlc.'l Disl'7
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ro~ 'Na'll'icl {NMJ) Vo.bc:d1, PliannO.~ 0\'YJlCr
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Fa\1.i.onl\l l'f~ntt~e-ootic:al-$, f11c, db.~\ Axia PhAAnaceutical
-~-:r:R""'i'El'..--I~CTIC\'\1 OF YO~ P/>.CIU1Y. '1H~Y ~ INSPGOitON'At. OOSClR.YAtlOt-00~ NJO DO r-t
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DEP.ARTMSNT Oft Ht!AL'rH AND IWMAN :&f!RVICE!S .1-"001> ~ORIJG AOhtiNJS.fRATJC.1~
01 l~ICiT C:FICI~ ;'lllii'Ae!tlfllND Pl10'11'. NtltAOC:R ti)S Angeles Distda Office 1m1l-"ain;hHd ~viM,.CA 9-2612 949:8~~000 .
.lodu:~~ry lnlomuli\att; www.fda.gov/il~lndLJ~try
0/tTiitt~) OF IN~PfiC'riQN
1.:1Mt~~r'l017 ~ llMi'11'..1"(1J'
30UJ~ISQ.j
:if IXI:l du:ex; IN!IItvtt:lfl\L ro 'PiJ
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"l=tQ Twt C-a.seo < 4 > ( b} (4} Ve.rifieation fo1 (b) (4)
.tches fo!'
Tht'ovcd on 2tMarJ7.
C. Records were iusufficie11t regarding incubation of (o) (4) as 'foitows:
l) A~Qtding to manufac.turer'sjnstrucll01l3.. required to be nl (D) (4) incubator
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tJePAA.TMEtfl Of' flEAL1H AND ~iUMAil $!R\IICES FOOO M-ID bRt.JC A~IINISl'RAnotJ
OA'nl:tSI or.mQ;~GCllr)r~
Los Ange)e$ Dist1Jct Office
biSTif:"e1 CfF&CE /...ODREeS liND PHOil NUP~ai!R
l3Ma.r~027 2'1M111r20l71910l FLiliC!bild Jrvine.. cA 926l~ 9-4?~60$-25100
30l334U63fllduSir/lllfurmatl.oo: 'W"!W.&1).w/oclil~1.1'Y
Fl.fllU~~AJ.lF. STRE'2fACDRESS
fl\lsto.nlV l,llitlrmne~IXknJ:s, Inc:. dba A~a Pfulm,ncculit~l 1990 Woes!wcodBtvd ~tG !35 l'Y-PE:OFESfAilLI8HP,tEtlT tNSF0rn-o- ------ ......:_..--..em'. ~A.U Me ZIP 000&:
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DI:PARTM'SNT OP HE:Al'Tl-1 1\Ni> l'fUNAN SERVICES
ID\id~tJN.o n1LE C4'001MoUAltO ii\fi(i;:ffie~ID'IS ISSUflb -- - ----.- . -~-- - --------
FIRM t~A11.ii: tlf.lli!ET Ao~~s
P41Sion IV Phlllrftl-.ceufit:Aas. JiLe. dbR A.xi11 f'hQrmll~utwa.l l99(t Westwood. Blvd Ste llS ~STAi'Ei.N~i:IP-00!! ~-- tri>e~$wwi-f6iirkftmP!!C~'fll~-o------ - -t.oo 1\nje~.s, CA 900Z~4-DSO ?r.
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.... DEPARTMENTOf' Ht:Al.'rft ANb H1J1'11AN S.ER~CES
2'000 ;.NO DH.t.IG AOIAINtSnV.OON
IOI4iRtr.TWiti'ifAoull&~ ANo l)jtoNr.'!'l':rJu= oe..,.. -------,o-:: ~ , ~~er-,.,.E~C!'=': ~,,,= t{---- E~""'cn o,-.-: Tt-::-:otJ ---- ---t IM-:-::T:::-LM AJt~el~Dimi"t Otllce r)Mfl1'2() 1:t. 2J:tvM~Ol1 19101 Faircbild Irviue;, CA. 9UCl FEitltl!.WE:R' 9i')-60t-290\}. ;. 30t3J4iSo3fn V[~1
~=--:-:-~o:--~------- - --- OBSSRVADON 7
Sttiot c.ontrol is not exerc,ised over JabeHng l~ued fo.r use in drug prOO.uct Jabethg a_perations.
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0:14A~Tr.ti:Nf 01 til;At.lH AND tf~'-'AH .SifMCE'S FOOO ANU OAUO MMIM~1AATION
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LA. 483 ~o~ PRElfK.lUS WITtON 04!SCt.~ INSI?!::CTtONAL OBSERVATIONS Page 7 of7
http://www.fda.gov/medwatch
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