ʖ Sonya M Edmonds

Investigator

Signed By: Sonya M. Edmonds -S

Date Signed: 06-02-2023

10:33:50 

X 

PAGE 1 of 1 PAGES FORM FDA 483 (09/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS 

ʖ . . . . . . 

Lareese K Thomas 

Field Administrative Personnel 

Signed By: Lareese K. Thomas -S X Date Signed: 06-02-2023 10:34:37 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT ADDRESS AND PHONE NUMBER 

60 Eighth Street NE 

Atlanta, GA 30309 

(404)253-1161 Fax:(404)253-1202 

ORAPHARM2_RESPONSES@fda.hhs.gov 

DATE(S) OF INSPECTION 

5/22/2023-6/2/2023* 

FEI NUMBER 

3004034796 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Stuart P. Simpson, President 

FIRM NAME 

Delta Pharma, Inc. 

STREET ADDRESS 

114 W Mulberry St 

CITY, STATE, ZIP CODE, COUNTRY 

Ripley, MS 38663-1709 

TYPE ESTABLISHMENT INSPECTED 

Outsourcing Facility 

This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional 

observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an 

observation, or have implemented, or plan to implement, corrective action 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 and address above. 

 

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: 

OBSERVATION 1 

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 

Specifically, your firm failed to perform environmental monitoring (EM) sampling (viable and nonviable) in the ISO 7 room during the media fill on 5/26/2023. Because of the absence of EM sampling, 

the firm lacks the assurance of control of the ISO 7 room. Further, your firm’s media fill is not 

representative of your established drug production process where EM samples of the ISO 7 room are 

collected no less than (NLT) one time during filling. 

*DATES OF INSPECTION 

5/22/2023(Mon), 5/23/2023(Tue), 5/24/2023(Wed), 5/25/2023(Thu), 5/26/2023(Fri), 5/30/2023(Tue), 5/31/2023(Wed), 6/01/2023(Thu), 

6/02/2023(Fri) 

SEE REVERSE

OF THIS PAGE

EMPLOYEE(S) SIGNATURE 

Sonya M Edmonds, Investigator 

Lareese K Thomas, Field Administrative 

Personnel 

DATE ISSUED 

6/2/2023 
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."