DISTRICT OFriCE - Food and Drug Administration

department of health and human services food and drug administrat io n district office address and phone number oatersi of inspection id \ ' 3 ' 23-27...

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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