DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG A01.11NISTRATION
DISTRICT OF riCE
AOOf>ESS ..\NO PHONE NI.IMSER
OATE{S) OF INSPECTION
FD.\
40-10 ' nnh l ~mrall: Da l l a~. TX 7520-l 12141 253-'2()0
.3:!.3-27.3 0-.31:41-2:6-8.13-17.55~015
\pre~~way ~300
I FEI 'lUMBER -
30098 15000
lndu:.tr: lni'ormauon . WW\\ .r\la.gov. oc. indusu:
'li"ME .INO nn:.e OF'iNCI'I10L'AL TO WHOM REPORT IS lSSUEO -
TO:
\\ lllr.Jm 1.. Swall. R Ph.. Managing Part.n.:r
FIRM NN.~Sp~cialty
-
CompL'unding. LLC
CHY STATE AND ZIP CCOE
Cedar PJrk. TX 78611
-----STREET -- -----ADDRESS 1
2 11 South Bell Blvd.
TYPEOF ESTABLISHil.tENTINSPE"CTE'[)'_ _ _ _ _ __
___ _
Produca of IJmgs
--------- - - -- -----·- -- - THIS DOCUMENT LISTS OSSE"'VATIONS M ADE BY rnE FDA REFRESENTATNEtSI GURtNG THE INSPECTION OF YOUR FACILITY
THEY ARE INSPECTIONA<. OSSEi'lV,> fiONS A 'ID DO NOT REPRESENT A FINAl AGENCY DETERMINATION REGARDING YOUR COMPLIANCE IF YOU HA IE AN OBJECTION REGARDING AN CSSER 'l. ~JCN OR HA'It IMPLE.....IEliiTcO OR P'..AN TO IMFLE:\IENi CORREC IM .\CTIO~I IN RESPONSE TO AN OdSERVATICN YOU M,O Y C IS(;LSS Tt-'E CB.E.:- v N CR AC~CN ,'lf"H ThE FDA REPRES£ NTATIVE (S DURING THE INSPECTION OR SUBMIT THIS INFORI\.1ATION TO FOA AT THE ADDRESS ABOVE
~
Pl'l :; !.N INSPEC'1C,._ 0~ YOLR FIRM il ('. J'It O€ S ERVEO
OBSFRY:\110:\ :. I
Your firm has faikJ
l\)
establish aJ~quJtt: prot..:edures for condu..:ting appropr iate media till s imu lations.
Your most rt:ccnt media lill:- dated -4 30 12014 ::md I Ot lt 20 1-t for each of the o pcr:Jtors that work in the I SO 5 LAF hovd$ do nl1t dosdy si mulat\.' p!annc:J proJucU~)n. For exampk. the b (4 )
UR fR\' \ 1 10"- ;:;2
Yo ur firm h.!:> n •t t.>r.sur.:d uu; your facil it) is sLit:'!hl: de~igned v.. ith resp~cl to the llO\\ ofpt:rsonnd. in-proce:-s dto::ri:-~1::>. ami ri ni~hL'J ~tcrik drugs: the nt.:ed for room sc:grc.:gatiun anJ process s.:paration: an J the impact from h..:;:nin:..! -...::nuL:uion ::tnJ air conditioning (HVAC). air pressurization. anJ unidir~ct ional airflow. 10 prevent comaminJtitlO and oth~r hazan..ls to sterile drug:-..
\ . The.: :'mokc.: studies pcrfom1ed by your vend or in 9/201 4 for ISO 5 LAF Hood # I indicateu the presence of airl1lm in the ISO 5 L. \r l!ood r- I. anJ specili~aUy air backJlo\v into the IS0-.5 . There was no C.:\::l]UdlHHl t•flht'> li nding. n~..ln - uniJi :c.:clitmJI
B 1 h..: .. \t:..rrl..: Pw..:e.:bing Ronm .. Ius a \\indO\\ useJ :.b a pu~s through r'or diny glassware from tht: ISO 7 area to un..:Lls:-.ttic.:J ,1n:a. Your firm has not dc.:temHned \\hcther there is :10 in11u:x of air from t.he um:b.ssi lied a.rea into the.: (:-,{ J 7 \\hen thl.! wt nJow is ope ned.
.11
EMPLOY EElS) 'lAME ANO TITLE
tPrll:l or ry~ l
DATE ISSUED
SeE
R!:'lt:.o St;
:. 5 20l.S
OF T-1/ S ~=
"-"'
FORM FDA 4 i!3 (9•061
FRc\.10t, S EDITION OBSOLETE
INSPECT10NAL OBSERVATIONS
Pag e 1 o f 3
DEPARTMENT OF HEAL T'H AND HUMAN SERVICES
FOOD AND DRUG ADM INISTRATION
OATEtS) OF INSPECTION
JISTRICT Of'FICE ADDRESS AND PHON E N UMBER
FDA.
4040 North Ct:ntral ExpreSS\\ a> t/300 Dallas. T\ 75204
I
3 23-27: 30-31: -1 1·2:6-8: IJ-17: 5 51'10 I :5
----- - 4
[FEI NUM BER
1:! 1 ~ )'25 3 - 5~00
3009815000
lndu:'tl') ln!~>mlati<>n www fila gO\< oc in dustry \iM~E ~"'C
TO:
-J"'LE.OF INDI'IlOU~l TO WHOM REPORT IS ISSUED
\.>. i!lt.tm L. SwaJ!. R Ph . \.fanaging Parma
- -- -
FIRM NA,\1E
-·--··
·-- -
STREF!l' AOORESS
Sp..-c: 1 :1 lt~ l. ompoundmg. Ll.C CITY ST;. TE AND ZIP
Ced::t~
21 I South Bell BlvJ
COOE- -
TYPE OF ESTABLISHMENT INSPECTED
Pari--. TX 7861 J
Producer of Dmgs
OB TR\' \ TIO:--.: :=:; ·our lirm has fai led tO c:stabl ish <.u1d implement adequate operational procedure:> designed micr0biolngical contamination of drugs purporting to be stl;'rilc.
to
pren:nt
YPur b 4 used for the depyrogenation ot' glassware! used in aseptk processing was qualil1ed on 3 24 2015 using lhc b 4 ) ( lbH•> (b) (4 ) ). ·nte dir~ctions for use for the test indicate that the ........................ b _.
To date. yot1r tirm has not dcknnined "her~ th b) (4) _.....__ __
•
ORSER V
\ri O~
. tbl(4j'
:;..f
· Your lim1 ha.-. not establi::.hed adequutc \\fin.en Standard Op~rating Procedures to ensure proper maintcnan~c of as~pck prvcessing areas nnd cquipmt.:nt used in those areas. .::.p..:citiL:all:.
Your t"trrn bJs t1lH est.1bli~h~J ''\Titten procedures ::>teril...· Jru:;: pr~)Jucts.
Your linn l'nilt:t.l to ensurl.! the accutaL:) of the
lh~H dl!sc rib~.:
labd ~
the cleaning of gbss\\J.n: used in the production o(
used in the tinishcd preparation.
SpccJiicall~.
Tht: proJud. Methylcobalami n, RG3 (90%)/Cyclodc'\lrintNicotinamide :?.mg 2mg/60mg/50m~/ml ~usa ! Spray.
111'1 # 12222014 a6). wa~ proJll\:e-d on 12/ 22/101-1 . Acconling.lo (;Ompoun~lillg r~cord s . the 13UD for the product.
E,E_!~. .~.;: f E]M , LOY.~~1t,. lS SIGN,!CAT ./U _R
P'..l£r_·'__ __ ~
4
FOR M FDA 483 19'08 1
1
E- A f 2--
PRE'.10US EDITION OaSOLETE
EMPlOYEE(SlNAME
AND TITLE (PnnlorTypeJ
'kl'h cn II hro 11 fl. ln"-''llh tt.>r
INSPECTJONAL OBSERVATIONS
-.., OATE ISSUED
---.
5 5 '20 15
Page 2 of 3
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRAT IO N DISTRICT OFFICE ADDRESS AND PHONE NUMBER
OATErSi OF INSPECTION
ID \ ~o..:o
\orth Ccnffiil DJIIas. T "\ 7510-+
1:.\prcssv.,;~;.
' 3 ' 23-27: 30-31:4 1-2:6- 8:13- 17:5 5 2015
::JOO
,,
___
-
FEI NUMSER
!~1 4 1251·5~00
' 3009815000 __j
Indust ry I nfom~:Hi<>n \>ww fJa,go' 0(; indusu; NMIEANDTITLE oF INOMDUAL TO
~t-ICii1"REP5firiS'issueo
- - - - -- -- - --- ·
- ·-
-
-·--------- - - -·-
---
- --
TO: Wilh:un L. Swli l. R.Ph.. Managing Parmer
F-iit-ANMI.E- -· - - - -·· · -- - -·- - - ---· t;pcctalr;. lompounJin~. LLC
----- -~
_ . - - - - - - ___
I
__
Cl "Y ST<\TE AND ZIP COOE
l .:dar Par\... T\ .,8613
-- :Vkth~
- -
STREETAOORESS
-- - -
- --·-· -· ···· ··- -·-
-
:_11 So~~~el l B l~:- _ _ _ _ _ _ _ _ _ _ - · _ TYPE OF ESTABLISHMENT I NSPECTED
- -- - -----
-
I Prodw.:er of Drug~
- --------------
k·\.lD::tl.tmin RG 3 190,o •)) 'C: clode\trin. · icotiii.Ullid~ 2mg/:::mgi60mg. 50mg mll\nsal Spra:, (lot r: 12222()1 ~ a 6. Pr~"'Juct1on Dntt!: 12: 22 20 1-l- ). \\aS 2'5 ::!0 15. Howe\t:r, the label on the distributl!d proJu~t had a Jd~r~rt:nt Bl 'D or 2, 1-l- 2015. The producl \\OS di spenst:J on 1/ 12:20 1.5 .
--..)
--~-------
-
-- OATE ISSUEO - -
s 5 ~0 l5 FORM FOA 483 /9108i
PR!::I,IOUS ECITION OeSOLETE
INSPECTIONAL OBSERVATIONS
Page 3 of 3