Dt:J>AR'I o\-n:rrr OF Il EAL I ll AM> Ill !

\IAN SEJW JCt:S

1000 AI\ I) IJR lJ(j ADMINIS"!Rt\ liON
D<STRJCT AOOI<ESS A"DPHO'E N"J\<BEI<
~ TElS~ OF ~~SPC';K)N

404 0North Central Expressway, Suite 300 08/24/2015 - 09/24/2015 *

Dallas, TX 75204 FEINliVBER
(214) 253-5200 F'ax: (21 4) 253-5314 3000717703
Industry Information: www.fda.gov/oc 1 1ndustry
NAME ANOllrtE OF NOIV10l1Al fOWHOMRI "'Q!ll SSVEO
1
-

TO: Bruce w. Bagley, General Manager

FU~MNAVE
STREET AOORESS

PharMEDium Serv1ces, LLC 12620 W Airport Blvd Ste 130

CITY STATE ZIP CODE COVNTRY fVPE ESfABL.lSHMENf INSPECTED

Sugar Land, TX 77478-6200 Outsourcing Facility

l'h1' do..:um..:nl li.;h llhs~!n,llitllh m.Hk h) lh..: II >A r..:pre~..:lllali\..:(s) durmg the inspection of~o ur facility. l'h~!} arc in~pcctional
oh~cn <~lmns. and do nlll n:prc,lnt a tindlt\g.cm:~ detcrnunation rcg,udmg. :.our compham:c. II you ha\e an ohJetuon rcgardrng.an
ohsen;~tion. or IIJ~c implcmcutcu. or plan Ill implement. corrective .tl.'lton in rc~pon~c to an oh,cr"alion. )llll 1i1il) di~l.'ll!>~ the ohjcctivn or
action \\ ith the I'DAn:prcscnl<lllvc(s) durmg the m'peclton or suhmll this 111forma1ton 10 I'D A al the addrc~~ abtn c. II )OU ha~c an~
tiLICSiwn~. plcJo.e cuntat:l FDA mthe phone numhcr and nudrcss ;1bo~c

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

Specifieall).

On 08/24/20 15, 'v\1! obscn cd }OUr firm's pharmacist placing I(&) head inside your firm's ISO 5 Laminar
1\ir Flow hood while collecting tht: finn's produced drug product. orepinephrine 4mg [(b )J4)_ J 250
mL 5% Dextrose Injection. U P. product code [~}j4} ] . Expiration date 10/2 1/2015, Lot number
15236112S. Yo ur lim1's pharmacist failed to follow yo ur firm's documented SOP. CPS-305, Effecti ve
Date : 04/0 1/20 15. Version 13.0. titled Personnel Gowning and Aseptic Technique and Controls, which
states "... Do not lean over. in. or against hood /hood s urface and avoid having sleeves touch the s urfac e
or components."

OBSERVATION 2

Each batch or drug product purporting to be sterile and pyrogen-free is not laboratory tested 10 determine conformance to
such requ irements.

Specifically,

Given the observed inadequate aseptic processes at your firm, testing is deficient in that your firm failed
to perform sterility and endotoxin tes ting on each produced lot o f' drug product prior to release an d
distribution. Your firm repo rted sterility testing is o nly performed o n~~{t>f(4) I
0Ctif(4) ) o f' the s terile drug products produced at your facility b 4) f. For example, your firm
distributed the following finished drug products prior to s terility testing:

E.."'.OYEEtS)SIG"-'lURE

Jason R. Caballero, Investigator 'r

~ ,f, ~M D"TE ISSUED

SEE REVERSE Steph en D. Brown, Investlgator

. ~-:?'~
09/24/2015
OF THIS PAGE Carner son E .. Moore , Investigator .- ~- ~
'
~OHM ~ llA ~83 (091081 PRtVIOUS I DITI()t. OfiSOilTI I'ISPHTIO:'iA I. O RSE R VA I'IOi'l::. PAtol I m 'PAGE\
 llEPAH f~tt::\T Of' llf.AI.TII ,\ "'1 0 lfl ii\JA N SE llvtCI-:S
1001) AND DRUG AOMINIS.I RAliON
DISTRICT ADDRESS AND PHONE NUMBER
DATE($) OF INSPECTION

4040 North Central Expressway, Su~te 300 08/24/2015 - 09/24/2015 *

Dallas. TX 75204 F1NU'I9-ER
(2 14) 253-5200 Fax: (214) 253-5314 3000717703
Industry Information: www.fda.gov/oc/industry
NAME ANO TITLE Of INOIVJOU'AL TO WliOM REPORT ISSUED

TO: Bruce W. Bagley, General Manager

f:tRMitAME STREET ADDRESS

Ph~rMEDium Serv~ces, LLC 12620 ~~ A~rport Blvd Ste 130

CITY SlATE ZIP CODE COUNTRY TYPE E$TA8liSHMENT INSPECTED

Sugar Land, TX 77 4 78-6200 Outsourc~ng Fac~l~ty

orcpincphrine 4mg(b) (4) } 250 ml 5% Dextrose Injection. USP. product code [ b)J 4} I
total units compounded, Expiration date I0/2 1/2015. Lot number 152361 12S. was prepared on
08/24/2015. \vas sh ipped on 08/25/2015:

Magnesium Sulfate 4g Kt>H 4r 1 50m L 0.9% Sodium Chloride, USP. product codd t>f{4 ) J
total units compounded, Expiration date I 0/09/2015, Lot number 15237091 S, was prepared on
08/25/20 15, was shipped on 08/25/2015;

Vancomycin HCI 2g Kt>H 4r l 500mL 0.9% Sodium Chloride Injection. USP, product code
Kt>J(4 ) 1total units compounded, Expiration date 09/25/2015, Lot number 15238397S. was
prepared on 08/26/2015, was shipped on 08/26/20 15;

Oxytocin 30 Units [(5) (4) 1 I OOOm L Lactated Ringer's, product code Kt>J (4 ) 1 total units
compounded. Expiration date I 0/04/2015, Lot number 1523 711 IS, was prepared on 08/25/2015,
was shipped on 08/25/2015.

**THIS IS A REPEAT OBSERVATION FROM THE 2013 ESTABLISHMENT

INSPECTION* *

OBSERVATION 3

Testing and release of drug product for distribution do not include app ropriate laboratory determination of satisfactory
conformance to the identity and strength of each active ingred ient prior to release.

Specifically,

Potency testing is deficient in that your tirm does not perform potency testing on each lot of produc t
prior to release and distribution . Potency testing is only performed on ~ ([{t>) {4) J
Kb)(4 ) ) of the drug products produced at your facili ty Kb) (4 ) t. For example, your firm
distributed the followi ng finished drug products prior to potency testing:

Norepinephrine 4mg Kt>H 4 Y 1 250 mL 5% Dextrose Injection, USP, product code Kt>f(4 ) I

~
O..-.TE ISSUED
-a"'_'_
Jason R . Caballero, Inve~tigator ~
SEE REVERSE Stephen D. Brown, Invest~gator ~
09/24/ 2015
OF THIS PAGE Camerson E. Moore, Investigator _..-- __....---~
i

WKM tOA U (09101) PltlVIOIJ' >DITIOh OOSOI.tn INSP ECT IONA L OBSI::R\',\TIOf'IS PA<..L ~ O t < PAOLS
 OEPA HTI\1:\'T OF IIEALTIJ i\~1) lll i\11\N SEHVICt:S
I OOD AS() DRUG AOMINISTRATIO'l
OtST~IC r AOO~ES$ AND PHONE "'U"IIf.R OATE($) Of' INSPECTION

4 040 North Central Expressway, Su~te 300

Dallas, TX 75204
08/24/2015
FEINU~6ER
- 09/24/2015 *
(214) 253-5200 Fax: ( 214) 253 -531 4 3000717703
Industry Information: www . fda.gov/oc/industry
NAME ANO TITlE Of INOIVtOOAl TO AIHOM REPORT :SSVEO

TO: Bruce w. Bagley, General Manager

FI.R.MNA.Yf STREET AOORESS

PharMEDium Services, LLC 12620 w Airport Blvd see 130

CITY STATE ZJP CODE. COUNlllV iYPE EST ASUSHMENT INsPECTEO

Sugar :.and. TX 77478-6200 Oucsourc~ng Facility

total unit s compounded . Expiration date 10/2 1/2015. Lot number 152361 12S. was prepared on
08/24/2015, was shipped on 08/25 '20 IS~

:VI agnesium Su lfate 4g [(b } (4 }

l 50ml 0.9% Sodium Ch loride, US P. prod uct codc Kb } (4 } J
total units compounded, Ex piration date 10/09/2015 . Lot number 15237091 S. was prepared on
08/25/2015. was shipped on 08/25 / 20 I 5;

Vanco mycin HCI 2g ~bf(4) l SOOmL 0.9% Sodium C hloride Injection, USP, product code
[~I(4} I total units compounded, Exp iration date 09/ 25/2015, Lot number 15238397S, was
prepared on 08/2 6/20 15, was shipped on 08/26120 15;

Oxytocin 30 Units r(b (4 ) J I OOOm L Lactated Ringer's. product code [~)_{4) Jtotal units
compounded, Exp iration date I0/04/20 15, Lot number 15237 11 IS. was prepared o n 08/2 5/2015,
was shipped on 08/25/2015.

**THI S IS A REPEAT OBSERV AT ION FROM THE 2013 ESTABLISHMNT

INS P ECTION**

OBSERVATION 4

Laboratol) controls do not include the establishment of scientificall) sound and appropriate specificattons and test
procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Spectlically.

The upper and lower potency limits established by your lirrn for injectable drug products are outside of the USP acceptable
rang~ of90o-110%. For example

Oxytocin 20 Units per Liter is ~t>) (4)

Oxytocin30 Units per Liter is b)(4)
Oxytocin 60 Units per Liter is b)(4) ~
EMPI.OVEE(S) SIGNATUilE ~ DATE ISSUED

Jason R. Caballero, Investigator~ W'

SEE REVERSE Stephen D. Brown, Investigator ~/
09/24/2015
OF THIS PAGE Camerson E. Moore, Investigator ~ ~
.

tOR ' I tDA SJ (091081 PRl \"IOU~ lDITIO'< OO>OI.ETL INSP ECT IONAL O J.IS t:RVA TIONS PAGEl m 'PAGI:S
 llEP\In'i\ II :N' I OF II EAI : I'I I i\"' lllll Mt\1' SERV I\ t:S
I CX)I) ANI> I>Rl!Co AI>MINIS IRA liON
DoSTRICT ADDRESS A~O PHONE NWBER
DUErS) ~ ~SPECTION

4040 North Central Expressway, Suite 300 08/24/2015 - 09/24 /2015 *

Dallas. TX 75204 ~E.1N\J~BER

(214) 253-5200 Fax: (214) 253-5314 3000717703

Industry Information: www.fda.gov /oc/industry
NAIJIE AND TITt.E OF INOIV OUAL. TO WHOM REPORT ISSUED

TO: Bruce i':. Bagley, General Manager

~ I RM NA.ME Sfi.~EET ADDRESS

PharMEDium Serv1ces, LLC 12620 W Airport Bl vd Ste 130

ClrY STAlE ZIP CODE COUNTRY TYPE ESTAEJi.IStiMENT INSPEClEO

Sugar Land, TX 77 478-6200 Outsourcing Facility

OBSERVATION 5

Aseptic processing areas arc deficient regarding the system for cleaning and disinfecting the room and equipment to produce
asepuc conditons.

Speclflcall)',

Your tirm uses a non-sterile cleaning agent ([ bl14 j ) lor the internal and
I
external cleaning an d sani ti:tation of a ll your linn 's ISO 5 Lam ina r Air Flow hood( bl.14 ) I
[(b)(4 ) J. Also, your tinn uses a non-
sterile cleaning agent [{b) (4 ) I in the cleaning and sa nitizatio n of the ISO 7 areas or the
cleanroom on reb -(4) j.
In addition. the e nviron mental monitoring co ndu cted in the ISO 5 Laminar Ai r Flow hoods and
adjoining ISO 7 a reas is defi cient in that:
The perso nnel working in the ISO 5 Laminar Air Flow hoods arc monito red [~H41 J and nut on
Kb )(4 ) j.
The walls in the ISO 7 adjacent area are monitored [ ttl {4 } J and no t o n [~)J4 J
[(t5f{4) I.

OBSERVATION 6
The batch production and co1mol records are deficien1 in that ahey do not include specimen and copy or labeling.
pecifically,

Your tirm's batch production records do not include the shipper label which includes relevant labeling
infonnation such as the ad verse event reporti ng contact information.

OBSERVATION 7

r he labels of your ou t ~o urcing faci lity's drug products are deficient.

Th e labels an d containe rs of your ou t sou rci ng facility's d rug products do not include info rmation
requi red by section 503B(a)( 10)(A) a nd (B).

SEE REVERSE
EMPI.OYEEtS)SIGNATURE
Jason R . Caballero, I nvestigator
Stephen D . Brown, Invest1~ator
*-~~
~
f.. eJ,~
~
D"TE SSUED

09/2 4 /20 15
OF THIS PAGE Camerson E . Moore, In vest1gator - ~
i

f"OR\1 fDA ~U (09108) P1tt VIOLS EDITION OOSOI fTF INSPCTION1\ L O BSE IWATIONS PAGE Of S PAGt~
 OF:I'AHT:\JENT OF IIEALTII ANO ll ti i\IA:-. SEilVICES
HX)() A "lf) ORU(i 1\PMINISTRA I ION
OfSJRICl AOORESS ANOP~E M..WBER
CAlEIS Of' INSPECTION

4040 North Central Expressway. Suite 300 08/24/2015 - 09/24/2015 *

Dallas, TX 75204 rerNUM8ER

( 214 ) 2 53 - 52 0 0 Fax : ( 2 1 4 ) 2 53 - 53 14 3000717703

Industry Information: www.fda.gov/oc/industry
NMIE AND TITlf Of' INCIVIOUAl TO _.,.tOM REPORT ISSU ED

TO : Bruce w. Bagley, General Manager

ftR-.A NAME STREET ~OORESS

PharMEDium Serv1ces, LLC 12620 w Airport Blvd Ste 130

CITV STATE ZIP COOE COUNTRY TYPE ESTABLIS....<ENT INSPE'CTEO

Sugar Land, TX 77478-6200 Outsourcing Fac~lity

Specifically.

The following information is not found on some of your drug product labels, as required by

503B(a)(10)(A) :

1. The statement "This is a compounded drug"

2. The date that the drug was compounded .
3. The inactive ingredient s, identified by established name and the quantity or proportion of each
ingredient.
The following information is not found on the container labels for products you produce, as described
in 503B(a)(10)(B)) .
1. Information to facilitate adverse event reporting : www.fda.gov/medwatch and 1-800-FDA
1088.
Examples of drug product labels that do not contain this information include:
HEPARIN 25,000 USP Units ~1:)[(4} ] 250 ml 5% Dextrose Injection USP
MAGNESIUM SULFATE 25 gOC~l(4I J 250 ml Lactated Ringer's Injection USP
Vasopressin 40 Units Kb) (4) 1100 ml 0.9% Sodium Chloride Injection USP
For purposes of 503B(a)(lO)(B) container labeling, the clear plastic bag enclosing you r bagged products
should be considered the "container" for purposes of this requirement and bear the information
required by 503B(a)(lO)(B).

01\TES OF INSP ECTIO:"l:

08/2-l/20 15( Mon). 08/25/20 15(luc). 08/26120 15( Wed). 08127/20 15( I hu). 08128/20 15(Fn). 08/J 1120 IS(Mon). 09101120 15( I uc}.

09102120 15( \\ cd), 09/03/20 15(Thu). 09/04120 15(f'ri}. 09110'20 15(Thu). 09114120 15( Mon). 09115120 15(Tue). 09116'20 15( Wed).

09/ 17/20 15(Thu). 09/23/20 15(Wcd). 09/24120 15(Thu}

f 1,APlOYEEIS) SIGNATURE tf!t_~J DATE ISSUED

Jason R . Caballero, Inve st iga t or /J~,v. '~- 11{1

SEE REVERSE Stephen D. Brown, Inves t igator ~~ ~ 09/24/2015
OF THIS PAGE Camer son E . Moo re , I nves tig a t o r - ~
'
tORM F DA 41J 109101) 1'1\CVIOUS ~DI TtON OOSOLtTE 1 1'/SPECfi O~AL OBS1WATIONS Pi\G( S OF~ Pi\G(~
The observations of obJeCtionable cond1t1ons and pract1ces lis ted
on the front of th1s fo rm are reported

1 Pursuant to Sectron 704(b ) of the Federal Food , Drug and

Cosmetrc Act, or

2. To assist frrms Inspected rn complying with the Acts and

regu lations enforced by the Food and Drug Admrn rstratron

Sectron 704(b) of the Federal Food, Drug , and Cosmetic Act (21
USC 374 (b)) provrdes .

"Upon comp letion of any such rnspection of a factory ,

warehouse , consulting laboratory , or other establishment, and
prior to leaving the premises . the officer or employee making the
rnspectron shall grve to the owner, operator, or agent rn charge a
report rn wrrting setting forth any condrtions or practrces
observed by him which, in his judgement. indicate that any food ,
drug , devrce , or cosmetrc rn such establishment (1) consrsts rn
whole or rn part of any filthy , putrid , or decomposed substance,
or (2) has been prepared , packed , or held under insanitary
conditions whereby it may have become contamrnated with filth ,
or whereby rt may have been rendered rnjurious to hea lth. A
copy of such report shall be sent promptly to the Secretary "