Three FDA Warning Letters due to Unanswered Requests for Records

The U.S. Food and Drug Administration (FDA) has issued three somewhat similar Warning Letters. In all cases, the FDA wanted to verify compliance with CGMP. Therefore, the agency sent electronic requests for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4). These requests were not answered, and attempts to contact the companies by phone also failed.

The FDA points out that "it is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a)." Because the firms failed to respond to the requests, the FDA has no indication of the level of quality and is unable to confirm compliance with CGMP and other applicable requirements.

Finally, Warning Letter were issued, which are publicly available on the FDA homepage:

The first Warning Letter dated 12 September 2023 was sent to a manufacturer of over-the-counter (OTC) drug products located in the United States. The FDA asked the company to respond to the Warning Letter within 48 hours to confirm or update the registration and/or drug listing status. FDA may conduct an inspection to verify the information provided and to evaluate the compliance of the manufacturing operations.

The second Warning Letters dated 14 September 2023 also concerns a US OTC manufacturer, who produces, among others, hand sanitizers. Again, the agency gave 48 hours to respond and to confirm or update the registration and/or drug listing status.

The third Warning Letter dated 18 September 2023 was sent to a Chinese company, registered with the United States as a manufacturer of OTC drug products. Based on import records, there were multiple shipments of drug products into the United States. After repeated requests from the FDA for records and other information, the firm finally responded that it is “not prepared to allow the FDA to audit and inspect”. All drugs and drug products manufactured by the firm were already placed on Import Alert 66-79 ("Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection").

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