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

,:p-1 ~u..mn~

J01Jl4!S6:3

!'#At/ At""ffi TIT\.E" Qfi'iNDM~;JV.'Il 'TO WHdM REiPmf'r IS liS$

ro~ 'Na'll'icl {NMJ) Vo.bc:d1, PliannO.~ 0\'YJlCr

i'mia ttAUIJ

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

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

- - -

"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

- - --- - ---- ---

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&:

L.()s AA&e!d1

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.

.... 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.

Sp

----

------------ ------------

' .

0:14A~Tr.ti:Nf 01 til;At.lH AND tf~'-'AH .SifMCE'S FOOO ANU OAUO MMIM~1AATION

I.,----,.~-:---.......,.~~""::":':":~=:':"=,------------- - "1'-=-:=~=-::==~-----0IS.TRLCT ~riCE ,\t~ORfiS. PHON!; ~t.tOEFI OATE(S} OF l'i~S'f.:C"flotl

LA. 483 ~o~ PRElfK.lUS WITtON 04!SCt.~ INSI?!::CTtONAL OBSERVATIONS Page 7 of7

http://www.fda.gov/medwatch

APPLIED_FusionIVPharmaceuticalsIncdbaAxiaPharmaceuticals_LACA_483Amend2_03-23-17_Redacted_Page_1APPLIED_FusionIVPharmaceuticalsIncdbaAxiaPharmaceuticals_LACA_483Amend2_03-23-17_Redacted_Page_2APPLIED_FusionIVPharmaceuticalsIncdbaAxiaPharmaceuticals_LACA_483Amend2_03-23-17_Redacted_Page_3APPLIED_FusionIVPharmaceuticalsIncdbaAxiaPharmaceuticals_LACA_483Amend2_03-23-17_Redacted_Page_4APPLIED_FusionIVPharmaceuticalsIncdbaAxiaPharmaceuticals_LACA_483Amend2_03-23-17_Redacted_Page_5APPLIED_FusionIVPharmaceuticalsIncdbaAxiaPharmaceuticals_LACA_483Amend2_03-23-17_Redacted_Page_6APPLIED_FusionIVPharmaceuticalsIncdbaAxiaPharmaceuticals_LACA_483Amend2_03-23-17_Redacted_Page_7