r.

nPY
DEPARTMENT OF HEALTH AND HUMAN SERVICES
moo AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHOl'E NUlo!BER OATE(SJ OF INSPECTION

4040 North Central Expressway, Suite 300 5/30/2018 - 6/11/2018*

r(I NVto'BFR
Dallas , TX 7520 4
(214) 253 - 5200 Fa x : (214) 253- 5314 3012038236

NANE' ANO TITLE OF INOMOUAL TO WHOM REPORT ISSUED

Mr . Rene F. Garza , CEO

FIRM NAME STREET ADDRESS

Stonega te Pharmacy LP 2501 W William Cannon Dr Ste 203

CITY, STATE. ZIP OOOE. COUHTAY TYP£ ~STABUSllMENT '" S""CTEO

Austin , TX 78745- 5255 Producer of Sterile and Non- Sterile Drug

Products

This document lists observations made by the FDA representative(s) during the inspection of your facili1y. They are inspectional
observations, and do not represenl a final Agency dc1ermina1ion regarding your compliance. If you have an objection regarding an
observation, or have implemented, or plan 10 implement, corrective action in response 10 an observation, you may discuss the objection or
action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any
questions, please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM I OBSERVED:

OBSERVAT ION 1

Med ia fills were not performed that closely simulate aseptic production oper ations incorporating as
appropriate, worst-case activities a nd conditions that provide a cha llenge to aseptic operations.

Media fi ll conducted by your aseptic technicians do not represent routine production nor do they simulate worst
case scenarios or most challenging conditfo ns. For example, your firm produced a batch of Glutathione 5%
Inhalation Solution Lot # 04052018:86@39 consisting of r(b) (4) I each containing (b) (4) of product. In
addition, your firm has also produced a batch of Chorionic Gonadotropin IOOOOJU/ml Solution, Lot #
03202018:94@2 consisting of !l>H•J vials each containing <b><41 of product. Your fi rm routinely fills various size vials
(2m1-100m1) and batch sizes can be in excess of (b) (4 ) . Your firm 's current media fi ll test procedure involves
placing [(6) (-4) I
[(b) (4) I.
Thi is a. repeat observation from the previous inspection conducted in 2016.

OBSERVATIO N 2

Personnel hand washing proced ure was conducted in a way that may have cause the gowning apparel to
become contaminated.

On 6/5/2018, I observed the sterile technician remove her lab coat, cap and replace her shoe covers prior to
entering rhe clean side of the IS07 anteroom where she proceeded to wash her hands before sterile gowning.
During the hand was hing procedure, I observed tap water from the sink splas hing the front of her scrubs and

EMPl.OYEE(S) SIGM TURe DATE ISSUED

SEE REVERSE Patty P Kaewussdangkul , Investigator ~ 6/11/2018

OF THIS PAGE p., , ~

x =:'-·
~'='~.a)llOiC:.011

t'OllM tllA 483 (09108) PllEVfOUS LDmON OBSOLI:Th INSPECTIONAL OBSERVATIONS PAGE 1 of 3 PAGES
 DEPARTMENT OF HEALTH AND H UMAN SERVICES
FOOD ANO DRUG ADM fNISTRATION
rnsmlCT ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION

40~0 North Central Expressway , Suite 300 5/30/2018- 6/11/20 18*

FEIN\fl.IBER
Dallas , TX 7520 4
3012038236
(214) 253- 5200 Fax : (214 l 253 - 5314
MME AND TITlE Of NOIVIDUAI. TO WHOM REPORT ISSUl:D

Mr . Rene f . Garza , CEO

FIRM NAME STREET ADDRESS

Stonegate Pharmacy LP 2501 W William Cannon Dr Ste 203

CIN. STATE ZtPCOOE COUNTRY TYPE ESTABUSHMENT IHSl'ECTEO

Austin , TX 78745 - 5255 Producer of SLerile and Non- Sterile Drug

Products

splas hing on the Qoor next to her shoes which were covered with s hoe covers. She proceeded 10 don sterile
garments such as a sterile mask, sterile gown, sterile gloves but did not change her shoe covers that may have
been contaminated with microbiological organisms found in tap water that splashed on the floor during the hand
washing procedure and entered the IS07 buffe r room containing the ISOS laminar air flow hood.

OBSERVATION 3

......., _______
.................. are not used pr oper ly to verify the adequacy of the sterilization (b) (4)

s terilizes vials of Testosterone in (b) (4)

---------------­ ____
The sterile technician stated that b 4
- - -· However, your firm does not follow the manufacturer's insen which states that
..........

is to be (b) (4) . Your firm's sterile technician stated that the

. T here is no assurance that the
..--------
b 4 have been distributed that were

b) Your firm D 4 sterilizi ng Testosterone,

Testosterone/Anastrozle and/or Estradiol pellets in the (b 4 . However, you do not
(15) (4) used to house the pellets. The (15) (4) are
not processed or subjected to the same conditions as the pellets therefore there is no as urance that the (b) (4)
4
(b) (4 ) parameters utilized to sterilize rhc pellets are adequate. Approximately'(bH Y prcscriptions of Testosterone,
Testosterone/Anastrozole and Estradiol pellets were dispensed since 3/1/2018.

OBSERVATION 4

Stock solutions used in the preparation of sterile finished drug products are not (b) (4)sterilized nor stored
in sterile containers.

EMPl.OVEE(S) SIG"IAT\JAE DATE ISSUED

SEE REVERSE Patty P Kaewussdangkul , Investigator ~ 6/11/2018

OF THIS PAGE p~ p ~

~,..,.,,,
x ~t~40t•GRocttt

FORM FDA 483 (09,'08) PR£VJOUS !D1TION OftSOLETl: INSPECTlONAL OBSERVATIONS PAGE 2 of 3 PAGES
 r.OPY
DEPARTMENT OF HEALTH AND HUMAN SERVlCES

FOOD AND DRUG AOMINlSTRATJON

OISTlllCT ADOAESS NC) PHC>f,E NU\tBEA DATE(S) OF INSPECTIO'I

4040 North CenLral Expressway, Suite 300 5/30/2018 - 6/11/2018 ~

f'EI NUMBER
Dallas , TX 75204
(214) 253 - 5200 Fax : (214) 253-5314 3012038236

NA.VEANO mLE OF '"DIVIDUAL TO WHO,. REPORT LSSlJEO

Mr . Rene F . Garza , CEO

ARM NAME STREET AOoRESS

Stonegate Pharmacy LP 2501 W William Cannon Dr Ste 203

CllY. STATE. 21PCOOE COUNTRY lYPE tSTA8USl-NENT INSPECTED

AUS Lin , TX 78745 - 5255 Producer of Sterile and Non-Sterile Drug

Products

Your firm prepares [(15) (4) I, a stock o lution that is used as a component in the
production of Chorionic Gonadotropin Solution (HCG), an aseptically filled sterile injectable drug product of
various strengths such as but not limited to 5,000IU/ml and 10,000IU/ml. The rCb) (4)
,(b) (4) J stock solution is not[5 ) (4) terile and is not placed in sterile containers. The beyond use date for this
stock solution is {b) (4) I. The following lots of ~b) (4)
1 : Kb) (4) I
(D) (4 ) lhave been prepared without being b) (4)J sterilized nor stored in sterile
containers lo limit or reduce bioburden Lo control potential proliferation of bacterial endotoxins and were used io
the production of HCG in various strengths. Since 3/1/2018, approximatelyFl.Ejescriptions have been fu lfilled
of various strengths of HCG of which the rCb) (4) stock solution was used.

*DATES OF INSPECTION

5/30/2018(Wed), 5/31/2018(Thu), 6/01/2018(Fri), 6/04/20J 8(Mon), 6/05/2018(Tue), 6/06/2018(Wed),

6/07/2018{Thu), 6/08/20 18(Fri), 6/ 11/2018(Mon)

EMPl.OYEE(S) SIGNATllAE OATE ISSUEO

SEE REVERSE Patty P Kaewussdangkul , Inves t igaLor 'l2fll!. 6/11/2018

OF THIS PAGE p_,,~~

~ ...,,.
x ~"r:t~IGt.<lt>11

FOR."'! FDA 483 (09/08) PR£VIOUS uimoN oesoum INSPECTIONAL OBSERVATI ONS PAGE 3 of 3 PAGES