FDA issues warning letters to two firms for failing to respond to record requests

The US Food and Drug Administration (FDA) recently published warning letters addressed to two over-the-counter (OTC) drug manufacturers that have not responded to the agency’s requests for records.

On 12 September 2023, FDA posted a warning letter addressed to Gulf States International, Inc., documenting a series of attempts to contact the firm and request records and other information. FDA posted a similar letter to Zhao Qing Longda Biotechnology Co. Ltd., on 18 September that documented the agency’s attempts to contact the firm with a similar request for records and other information, and contained a note that the firm’s products are susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitution.

The two letters are the latest in a series of warning letters published by FDA where firms have been put on notice for violations, including failure to test for potential DEG/EG contamination (RELATED: FDA issues blitz of warning letters over testing violations and refusing records requests, Regulatory Focus 09 August 2023).

The agency also recently published a warning letter to an OTC drugmaker for multiple good manufacturing practice (GMP) violations, inadequate investigations into the source of contaminants or foul odors, and testing for potential DEG/EG contamination (RELATED: FDA reprimands OTC drugmaker for inadequate ingredient testing, contamination, Regulatory Focus 17 August 2023).

Gulf States International

FDA noted it sent two electronic requests to OTC drug manufacturer Gulf States International on 9 September and 27 September 2022 asking for records and information under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act and received no response. However, the firm did acknowledge the agency’s email on 3 October 2022 while not responding to the 704(a)(4) request. After several more attempts to contact the firm, Gulf States International “failed to respond to these attempted communications or otherwise provide the requested records or other information,” FDA wrote.

“Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility,” the agency wrote.

The warning letter states Gulf States International has 48 hours to respond and update their registration and drug listing status with the agency as well as provide a response to the records and information request. Gulf States International is also required to deregister its facility and delist its previously listed drugs with FDA if the firm is currently not manufacturing drugs, the agency wrote. FDA also noted it may still conduct an inspection of the firm “to verify information provided and/or to evaluate the compliance of your manufacturing operations.”

Zhao Qing Longda Biotechnology

FDA’s warning letter to Zhao Qing Longda Biotechnology notes that the firm manufactures OTC drug products, such as toothpaste for children, and that the drugs used by the firm during the manufacturing process are susceptible to DEG/EG substitution. The agency identified drug product shipments from Zhao Qing Longda Biotechnology after a review of import records.

After issuing three record and information requests electronically on 17 March, 6 April and 18 April 2023, FDA received a response from the company noting that they were “not prepared to allow the FDA to audit and inspect.” FDA followed up with a written request for records and other information on 28 April 2023, which resulted in a delivery failure notification.

As in previous warning letters where DEG or EG contamination was a concern, the agency informed Zhao Qing Longda Biotechnology that lethal poisoning incidents have occurred worldwide as a result of ingredients contaminated by DEG or EG. The agency pointed the firm toward the “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol” final guidance for meeting current GMP requirements.

On 29 August 2032, FDA said it placed the firm’s products on an import alert list. FDA explained that because it is unaware of the level of quality assurance of drugs manufactured at the firm’s facilities and cannot confirm its compliance with current GMP and other requirements, the agency “may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.”

“In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection,” FDA wrote.

Gulf States International warning letter
Zhao Qing Longda Biotechnology warning letter

FDA issues warning letters to two firms for failing to respond to record requests

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