Gulf States International, Inc.

Warning LetterOpen

Mr. Bret Holmes President and CEO Gulf States International, Inc. 302 March Street Union Springs , AL 36089 United StatesFEI 3007520648Issued Sep 12, 2023Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3007520648.

Violations1

Issue DateSep 12, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: Gulf States International, Inc.
Location: Mr. Bret Holmes President and CEO Gulf States International, Inc. 302 March Street Union Springs , AL 36089 United States
FEI Number: 3007520648
Country: United States
Issue Date: September 12, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

Gulf States International, Inc., a manufacturer of over-the-counter drug products, failed to respond to FDA records requests issued under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act on multiple occasions between September 2022 and September 2023, despite follow-up communications via email and phone. The company's refusal to provide access to and copying of manufacturing records constituted a prohibited act under section 301(e) of the FD&C Act, leaving the FDA unable to assess the quality assurance levels for drugs manufactured at the facility. The FDA provided the company 48 hours to confirm its registration status and indicate willingness to comply with the records request, or alternatively to delist all previously registered drugs and deregister the facility.

Gulf States International, Inc. FDA Warning Letter, September 12, 2023