FDA Warning Letter: Missing Tests, Missing Proof

In a Warning Letter dated 10 October 2025 and published on 21 October 2025, the U.S. Food and Drug Administration (FDA) addresses severe violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals at a Chinese manufacturer of OTC drug products.

Following a review of records and other information provided upon an official request, the authority found fundamental deficiencies in analytical quality assurance: the company failed to perform adequate finished product testing to confirm identity and strength prior to release, and no stability studies were conducted to support expiration dating. Moreover, incoming raw materials were not properly tested or verified for identity, and the reliability of supplier testing was not established.

Equally concerning was the absence of process validation and complete batch records, leaving the FDA unable to verify whether manufacturing processes were reproducible or controlled. The agency concluded that the company lacked sufficient analytical data to demonstrate product conformity with specifications and lifecycle control.

The extent of the shortcomings underscores the elementary nature of the GMP violations. This is particularly evident from one statement cited in the Warning Letter: “…this site does not prepare batch production records for every batch of our listed drug…”.

As a result, all products from the facility were placed on Import Alert 66-40, effectively barring them from U.S. entry. The FDA strongly recommended engagement of an independent CGMP consultant to perform a full six-system audit and oversee remediation efforts.

For further information, please refer to the Warning Letter to Foshan Yiying Hygiene Products Co., Ltd. on the FDA's website.