Promise Pharmacy, LLC, Palm Harbor, FL. Amended 483 issued 11/12/2018
HHS, ORA, FEI, 3013207472, FDA, Promise, Pharmacy, Palm, Harbor, FL, Amended, 483, 2018, 483, Inspections
HHS; ORA; FEI, 3013207472; FDA; Promise, Pharmacy; Palm, Harbor; FL; Amended, 483; 2018, 483; Inspections;
FDA, HHS, ORA
UCM628524 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER
OATE(S)OF INSPECTION
555 Winderley Place, Suite 200
10/15/2018- 10/25/2018*
Maitland, FL 32751 (407)475- 4700 Fax: (407) 475- 4768
FEJNUMBER
3013207 47 2
NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED
Mipal (Amy) Patel, Pharmacist - I n - Charge
FIRM NAME
Promise Pharmacy, LLC
C ITY. STATE. Z IP CODE. COUNTRY
Palm Harbor, FL 34684 - 3713
STREET ADDRESS
31 81 8 Us Highway 1 9 N
TYPE ESTABUSI-NENT INSPECTED
Producer of s terile and non- s terile produ c t s
This document lists observations made by the FDA representative(s) during the inspection ofyotu· facility. They are inspectional observations, and do not represent a final Agency detennination regarding yotu· compliance. Ifyou have an objection regarding an observation, or have implemented, or plan to implement, con-ective action in response to an observation, you may discuss the objection or action with the FDA representative{s) dming the inspection or submit this information to FDA at the address above. Ifyou have any questions, please contact FDA at the phone number and address above.
DURING AN INSPECTION OF YOUR FIRM I OBSERVED:
OBSERVATION 1
Procedures designed to prevent microbiological contamination of diug products purporting to be sterile are not.
Specifically, on 10/19/18, I observed the following:
· An operator blocked first pass HEPA filtered air dming the production of Bremelanotide, Lot
1019018@4, BUD 12/18/18.
· An operator did not move slow and deliberate in the ISO 5 environment when transfening partially
stoooered vials of Bremelanotide, Lot 1019018@4, BUD 12/18/18, from the compounding table to
fD' (4)
I
· An operator did not wear· a bear·d cover dming the production of HCG 2000ill Injectable, Lot
10192018@6, BUD 04/17/18.
OBSERVATION 2 The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, str ength, quality an d purity of diug products.
Specifically, yom firm does not perform a visual examination of finished dmg products prior to dispensing and distribution. On 10/16/18, I observed the presence of particulates in multiple bottles of Prednisolone and
AM ENDMENT 1
SEE REVERSE OF THIS PAGE
EMPLOYEE(S) SIGNATURE
Jennifer L Hu n t i ngt on, I nvest i gat or
F -JemttrL tb'llngtln
X OafeSl,J'led 1M 2-2018065126
DATE ISSUED
11/12/2018
FORM FDA 483 (09/08)
PREVIOUS EDmON OBSOlEJE
INSPECTIONAL OBSERVATIONS
PAGE 1of 6 PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER
OATE(S) OF INSPECTION
555 Winderley Place, Suite 200
10/15/2018- 10/25/2018*
Maitland, FL 32751 (4 07) 475 - 47 00 Fax: (4 07) 475 - 4768
FEJNUMBER
3 013 20 747 2
NAME AND TITLE OF INOM OUAL TO WHOM REPORT ISSUED
Mip al (Amy) Patel, Pharmacist - In- Charge
FIRM NAME
Promise Pharmacy, LLC
C ITY. STATE. Z IP CODE. COUNTRY
Palm Harbor, FL 34684 - 3713
STREET ADDRESS
31818 Us Highway 19 N
TYPE ESTABU SI-NENT INSPECTED
Producer of sterile and non- sterile p r oducts
Gatifloxacin Ophthalmic Solution, Lot 09042018@2, BUD 12/03/ 18. fu"..,
!bottles of Prednisolone and
Gatifloxacin Ophthalmic Solution, Lot 09042018@2 had ah-eady been dispensed and distiibuted.
OBSERVATION 3 The flow of components, diug product containers, closures and in-process materials though the building is not designed to prevent contamination .
Specifically,
A. The environment in which sterile, non-hazardous dmg products are produced does not meet the standards
of an ISO 5 environment due to the following:
· HEPA filters do not cover the entire room.
· There is no full assessment of the room's pressure differentials.
· Smoke studies were not perfo1med throughout the entire room.
· There is a non-classified~0 J l4 J
!from the ISO 8 Prep room to the ISO 5 sterile environment.
B. On IQ/18/18 10/19/18, I obse1ved the ti·ansfer of partially stoppered Bremelanotide, Lot 10192018@4,
from the stainless-steel compounding table to thef0 ' l4 J
the ISO 5 sterile, non-hazardous room. I
obse1ved thet ' l4 J
1s pa1tially located under a light fixture that does not have a HEPA filter.
OBSERVATION 4 Each batch of diug product required to be free of objectionable microorganisms is not tested through appropriate laborato1y testing.
AM ENDMENT 1
EMPLOYEE(S) SIGNATURE
SEE REVERSE Jennifer L Huntington, Investigato r OF THIS PAGE
F-,.,L- - Je'lrl'er l ~
X Dale S9'leO 1M 2·2018065126
DATE ISSUED
11/12/ 2018
FORM FDA 483 (09/08)
PREVIOUS EDmON OBSOlEJE
INSPECTIONAL OBSERVATIONS
PAGE 2 of 6 PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER
OATE(S) OF INSPECTION
555 Winderley Place, Suite 200
10/15/2018- 10/25/2018*
Maitland, FL 32751 (4 07) 475 - 47 00 Fax: (4 07) 475 - 4768
FEJNUMBER
3 013 20 747 2
NAME AND TITLE OF INOM OUAL TO WHOM REPORT ISSUED
Mip al (Amy) Patel, Pharmacist - In- Charge
FIRM NAME
Promise Pharmacy, LLC
C ITY. STATE. Z IP CODE. COUNTRY
Palm Harbor, FL 34684 - 3713
STREET ADDRESS
31818 Us Highway 1 9 N
TYPE ESTABU SI-NENT INSPECTED
Producer of sterile and non- sterile p r oducts
Specifically, your fnm dof _n~t pe1form sterility and endotoxin testing on batches of sterile hazardous and non hazardous dmg products o ><4~ials/bottles or less. Examples include, but are not limited to:
· Ascorbic Acid Injection 450mg/mL Injectable, Lot 07202018@19, BUD 09/03/18 · Arginine HCL 200mg/mL Injectable, Lot 02082018@13, BUD 03/25/ 18 · Magnesium Sulfate 500mg/mL Injectable, Lot 08282018@2, BUD 10/ 12/ 18
OBSERVATION 5 Testing and release of drug product for distribution do not include appropriate laboratory dete1mination of satisfactory confo1mance to the identity and strength of each active ingredient prior to release.
Specifically,
A. Your film does not perfo1m potency testing on all batches of sterile dmg products prior to release and distribution. Examples include, but are not limited to: · Ascorbic Acid 450mg/mL Injectable, Lot 07062018@2, BUD 08/20/ 18 · Magnesium Sulfate 500mg/mL, Lot 08282018@2, BUD 10/12/ 18 · Dexpanthenol USP 250mg/mL, Lot 02082018@15, BUD 03/25/ 18 · Se1morelin GHRP 6 GHRP 2 PF 6mg/3mg/3mg Injectable, Lot 08302018@13, BUD 02/26/ 19
B. Your fnm released and distributed l:!vials ofBremelanotide (PT141) 20mg Injectable Lot 05312018@4,
BUD 07/30/18, with super-potent results for Bremelanotide of 114.3% (specification [(t:5) L1-) I
C. Your fnm released and distiibuted
ials of Se1morelin GHRP 6 GHRP 2 PF 6mg/3mg/3mg
Injectable, Lot 05312018@3, BUD 11/27/ 18, with super-potent results for GHRP-2 of 112.4%
(specifications 90-110%) and GHRP-6 of 113.8% GHRP-6 (specifications[(t>) (Ll-) I
D. Your fnm released and distiibuted 4 vials of Se1morelin GHRP 6 GHRP 2 PF 9mg/9mg/9mg
AM ENDMENT 1
SEEREVERSE OF THIS PAGE
EMPLOYEE(S) SIGNATURE
Jennifer L Huntington, Investigator
Je'lrl'er l ~
x F - , . , L- Dale S9'leO 1M 2·2018065126
DATE ISSUED
11/12/ 2018
FORM FDA 483 (09/08)
PREVIOUS EDmON OBSOlEJE
INSPECTIONAL OBSERVATIONS
PAGE 3 of 6 PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER
OATE(S) OF INSPECTION
555 Winderley Place, Suite 200
10/15/2018- 10/25/2018*
Maitland, FL 32751 (4 07) 475 - 47 00 Fax: (4 07) 475 - 4768
FEJNUMBER
3 013 20 747 2
NAME AND TITLE OF INOM OUAL TO WHOM REPORT ISSUED
Mip al (Amy) Patel, Pharmacist - In- Charge
FIRM NAME
Promise Pharmacy, LLC
C ITY. STATE. Z IP CODE. COUNTRY
Palm Harbor, FL 34684 - 3713
STREET ADDRESS
31818 Us Highway 19 N
TYPE ESTABU SI-NENT INSPECTED
Producer of sterile and non- sterile p r oducts
Injectable, Lot 05242018@2, BUD 11/20/18, with super-potent results for GHRP-6 of 111.3%
(specificationsK6) -{LJ) I
OBSERVATION 6 There is no written testing program designed to assess the stability characteristics of chu g products.
Specifically, your fnm lacks written procedures for a continuous stability program; and your fnm does not perform stability testing for sterility or endotoxin on sterile hazardous and non-hazardous diug products. For example, Stability/BUD study for Ascorbic Acid 450mg/mL Injectable, Lot 05012018@42 to extend the BUD from 45 days to 90 days did not have sterility or endotoxin testing at the final test time point dated 07/27/18.
OBSERVATION 7 Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or pmity of the chug product.
Specifically, the validation of your fnm's[(O) (4) land [( b) 4) llack temperature mapping to ensure the
required internal temperatures are reached and maintained throughout batch for the required runtime.
OBSERVATION 8
Your firm released diug product in which the strength differs from, or its pmity or quality falls below, that which it purports or is represented to possess.
Specifically,
AM ENDMENT 1
EMPLOYEE(S) SIGNATURE
SEE REVERSE Jennifer L Huntington, Investigato r OF THIS PAGE
F-,.,L-- Je'lrl'er l ~
X Dale S9'leO 1M 2·2018065126
DATE ISSUED
11/ 12/2018
FORM FDA 483 (09/08)
PREVIOUS EDmON OBSOlEJE
INSPECTIONAL OBSERVATIONS
PAGE 4 of 6 PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER
OATE(S) OF INSPECTION
555 Winderley Place, Suite 200
10/15/2018- 10/25/2018*
Maitland , FL 32751 (4 07) 475 - 47 00 Fax: (4 07) 475 - 4768
FEJNUMBER
3013207472
NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED
Mip al (Amy) Patel, Pharmacist - In- Charge
FIRM NAME
Promise Pharmacy, LLC
C ITY. STATE. Z IP CODE. COUNTRY
Palm Harbor, FL 34684 - 3713
STREET A DDRESS
31818 Us Highway 19 N
TYPE ESTABUSI-NENT INSPECTED
Producer of sterile and non- sterile p r oducts
A. Quality Related Event Repo1t (QRE) dated 06/26/18: A complaint was received for Rx#~D) (6) 1for pa1ticles floating in the injectable a few days after reconstitution for AOD 9604 PF 6mg Injection, Lot 06182018@3, BUD 09/16/18. Your fnm pe1fo1med an investigation confnming the presence ofparticles
for multiple lots of AOD 9604 PF 6mg Injection. The probable root cause was identified as a problem with the AOD powder, Lot l(D) (4) lused to produce the batches. Your fnm failed to pe1fo1m a risk assessment assessing the impact and to take corrective actions. if indicated, regarding the following
AOD injectable batches using AOD powder, Lot KD (4) I that were released and distiibuted:
01162018@14, 03192018@2, 05142018@4, and 06182018@3 .QRB dat~d 02/09/18.
B. QRE dated 02/09/18: On 02/09/ 18, your fnm identified a ste1ility failure for Thymosin B4 PF 15MG
Injectable, Lot 01312018@1, BUD 05/01/ 18. Your fnm failed to take approp1ia~l c..~rcffe a.c..tions.:Jo...
perfo1m a risk assessment assessing the impact on other batches produced from b 4
(date repo1ted); and to take corrective actions, if indicated. regardirn~ the following batches produced in
your fnm's ISO 5 ste1ile, non-hazardous room fromKD) (4)
I
· Sermorelin PF 15mg Injectable, Lot 013 12018@2, BUD 07/30/18 · BPC-157 PF 10mg vial Injectable, Lot 01312018@3, BUD 01/31/18 05/01/18 · Arginine HCL, 200mg/mL Injectable, Lot 02082018@13, BUD 03/25/1 8 · Leucine/IsoleucineNaline 10mg/10mg/5mg/mL PF Injectable, Lot 02082018@4, BUD 03/10/ 18 · Dexpanthenol USP 250mg/mL Injectable, Lot 02082018@15, BUD 03/25/18 · Ascorbic Acid Injection 500mg/mL Injectable, Lot 02082018@11, BUD 03/ 10/18 · Ascorbic Acid Injection 500mg/mL Injectable, Lot 02072018@1, BUD 03/09/18
*DATES OF INSPECTION
AM ENDMENT 1
EMPLOYEE(S) SIGNATURE
SEE REVERSE Jennifer L Huntington, Investigato r OF THIS PAGE
F - , . ,L- - Je'lrl'er l ~
X Dale S9'leO 1M 2·2018065126
DATE ISSUED
11/12/2018
FORM FDA 483 (09/08)
PREVIOUS EDmON OBSOlEJE
INSPECTIONAL OBSERVATIONS
PAGE 5 of 6 PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER
OATE(S) OF INSPECTION
555 Winde r ley Place, Suite 200
10/15/2018- 10/25/2018*
Maitland, FL 32751 (407) 475- 4700 Fax: (407) 475- 4768
FEJNUMBER
301320747 2
NAME AND TITLE OF INOM OUAL TO WHOM REPORT ISSUED
Mipal (Amy) Pate l, Phar macist - I n - Char ge
F IRM NAME
Promise Phar macy, LLC
C ITY. STATE. Z IP CODE. COUNTRY
Palm Har bor, FL 3468 4- 3713
STREET ADDRESS
31818 Us Highway 19 N
TYPE ESTABUSI-NENT INSPECTED
Produce r of s teri le and non- s teri le p r oduct s
10/1 5/2018(Mon), 10/1 6/2018(Tue), 10/17/2018(Wed), 10/19/2018(Fri), 10/22/2018(Mon), 10/23/2018(Tue), 10/25/2018(Thu)
AM ENDMENT 1
SEEREVERSE OF THIS PAGE
EMPLOYEE(S) SIGNATURE
Jennifer L Huntingt on, I nvestigat o r
Je'lrl'er l ~
x F - , . , L - Dale S9'leO 1M2·2018065126
DATE ISSUED
11/ 12/2018
FORM FDA 483 (09/08)
PREVIOUS EDmON OBSOlEJE
INSPECTIONAL OBSERVATIONS
PAGE 6 of 6 PAGES
The observations of objectionable conditions and practices listed on the front of this form are reported:
1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the
Food and Drug Administration.
Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides:
"Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."
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