FDA WARNING_LETTER - Gulf States International, Inc. - September 26, 2023

This FDA Warning Letter (320-23-37), dated September 12, 2023, was issued to Mr. Holmes of 302 March Street, Union Springs, AL 36089. The firm is registered as an OTC drug product manufacturer, specifically for (b)(4) products.

The letter details a failure to respond to multiple FDA requests for records and information under section 704(a)(4) of the FD&C Act (21 U.S.C. 374(a)(4)). Initial electronic requests were sent on September 9, 2022, and September 27, 2022, which went unanswered. An email acknowledgment was received on October 3, 2022, but no response to the request. Further attempts to contact the firm by phone on November 16, 2022, and September 6, 2023, also failed to elicit a response.

The FDA states that refusing access to records as required by section 704(a) is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)). Due to the firm's non-response, the FDA has no indication of the quality assurance level for drugs manufactured at the facility.

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