Warning Letter to Chinese OTC Manufacturer: Violations concerning Identity Testing, Stability Program and Quality Unit

Recommendation

12/13 September 2024

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On 26 March 2024, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter dated 18 March 2024 to a Chinese manufacturer. The facility is registered in the United States and produces of over-the-counter (OTC) drug products, including Antibacterial Hand Sanitizer.

The Warning Letter is based on a review of documents submitted in response to an official request for records and other information.

The Warning Letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the following:

• Identity testing of incoming components: The firm did not conduct adequate testing to verify the identity of each component of its drug products, including active ingredient ethanol for methanol contamination.
• Finished drug product testing: There was a lack of appropriate laboratory determination of satisfactory conformance to final specifications for drug products before release, including identity and strength of the active ingredients.
• Stability program: The firm failed to establish and follow an adequate written testing program to assess the stability characteristics for the OTC hand sanitizer drug products.
• Quality Unit (QU): The QU did not effectively oversee the quality of drug manufacturing operations.

The FDA recommends engaging a qualified consultant to assist in meeting CGMP requirements before resuming drug manufacturing operations. Additionally, the letter emphasizes the importance of promptly addressing and correcting the identified violations to avoid further regulatory actions.

For further information, please read the complete Warning Letter to Deqing Jiarou Daily Chemical Co., Ltd. published on the FDA website.