DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OFFICE ADDRESS ANO PHONE NUMBER

DATE(S) OF INSPECTION

F DA
4040 Norrl1 Central Expressway Suite #300 

Dallas, TX 75204 

(214) 253-5200

J0/1 6-20; 23-24; 27/ 17
FEINUMBER

3009712882

Industry lnfonnation: www.fda.gov/oclindustry
NAME AND nTLE OF INDIVIDUAL TO 'MiOM REPORT IS ISSUED

TO: Mr. Kenneth L. Hughes, co-owner and President
I STREET ADDRESS

FIRM NAME

I 406 1F Bellaire Blvd.

.Prescription Labs, Inc. dba Greenpark Compounding Pharmacy
CITY, STATE AND ZIP CODE

TYPE OF ESTABLISHMENT INSPECTED

Houston, TX 7 7025- 1121

Producer of Sterile and Non-Sterile Drugs

THIS DOCUMENT LISTS OBSERVATIONS MADE BY TI-iE FDA REPRESENTATIVE(S) DURING THE INSPECTION OF YOUR FACILITY. THEY ARE INSPECTIONAL
OBSERVATIONS; ANO 00 NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COM?UANCE. IF YOU HAVE AN OBJECTION REGARDING AN
OBSERVATION, OR HAVE IMPLEMENTED. OR PlAN TO IMPLEMENT CORRECTIVE AC'OON IN RESPONSE TO 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 AN D A DDRESS ABOVE.
DURING AN INSPEC110N OF YOUR FIRM(@(WE) OBSERVED:

O BSERVATION #1
On l 0/ 17I17, an operator engaged in aseptic processing was observed with his upper torso inside the ISO 5 area
with partially exposed skin while wearing a non-sterile mask, goggles, and hairnet.
OBSERVATION #2
On 10/ 17/ 17, an operator was observed sanitizing his gloved hands with non-sterilc (b) (4) and then resuming 

a septic processing in the ISO 5 area. 

OBSERVATION #3
The wipes used for disinfecting the interior of the ISO 5 hood are not sterile. 

OBSERVATCON #4 

The IS? 5 classified areas were not certified under dynamic conditions. Specifically, unidirectional air flow was 

not verified under operational conditions. 


OBSERVATION #5 

There is no evidence that (b)

(4) 
 _ _ _ _ _ _testing is being perfonned for sterile products. For example,

A. Tacrolimus Aqueous Ophthalmic 1OmJ 0.03% Suspension, lot #083 12017@45 (Production date: 8/31117
B~on_d Use date: 12/29/17) was sterilized using a (5) (4)
·. There was no evidence that the(b) (4)
(b) (4)
test was performed.

l

EMPLOYEE(S) NAME AND TITtE (Pnnt or T}'Pe)

DATE ISSUED

' Stephen D. Brown. Investigator

10/27/2017
FORM FDA 483 9108

PREVIOUS EDITION OBSOLETE

INSPECTIONAL OBSERVATIONS

Page 1 of2

 DEPARTMENT OF HEALTH AND HUMAN SERVlCES
FOOD AND DRUG ADMINISTRATION
DATE{S) OF INSPECTION

DISTRICT OFFICE ADDRESS AND PHONE NUMBER

FDA
.
4040 North Central Expressway Suite #300
Dallas, TX 75204
(2 14) 253-5200
Industry Information: www.fdagov/oc/industry

10/16-20; 23-24; 27/17
FEI NUMBER

3009712882

NAME ANO TITLE OF INDIVIDUAL TO V\+IOM REPORT IS ISSUED

TO: Mr. Kenneth L. Hughes, co-owner and President
STREET ADDRESS

FIRM NAME

406IFBellaire Blvd.

Prescription Labs, Toe. dba Greenpark Compounding Pharmacy

TYPE OF ESTABLISHMENT INSPECTED

CITY, STATE AND ZIP CODE

Producer ofSterile and Non-Sterile Drugs

Houston, TX 77025-1121

OBSERVATION #6
b .............
4 

The use of the sporicidal disinfectant, ..._
con tact time of1Cb) <4 Yminutes has not been substantiated.

~~~~~~~---

, in the ISO 5 areas is inadequate in that the

EMPLOYEE(S) NAME ANO TITLE (Print or Type)

Stephen D. Brown, Investigator

FORM FDA 483 (9/08)

PREVIOUS EDITION OBSOLETE

INSPECTIONAL OBSERVATIONS

DATE ISSUED

10/27/2017

Page 2 of2