FDA Issues Warning Letter to Vietnamese Drug Manufacturer due to CGMP Violations

The U.S. FDA issued a Warning Letter to Yahon Enterprise Co., Ltd., a Vietnamese drug manufacturer, after a December 2023 inspection revealed significant CGMP violations. The letter, published on July 23, 2024, highlights these issues:

- Testing and Release: Drugs were released without proper quality control testing, failing to meet USP standards.

- Component Testing: Inadequate identity testing for components like ethyl alcohol and benzylkonium chloride was noted.

- Expiration Dating: A three-year expiry date was assigned without scientific support or stability data.

- Quality Control Unit: The company lacked validation for manufacturing processes, cleaning, record retention, and reserve sample storage.

The FDA demands a corrective action plan within 15 working days and warns of potential consequences, such as delays in new application approvals and product detention at U.S. borders. For details, see the Warning Letter on the FDA's website.