FDA issued a Warning Letter due to Inadequate Lab Testing Procedures

In August 2024, the U.S. FDA issued a Warning Letter to Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. following an inspection of their site in December 2023.

The Warning Letter highlights significant violations of CGMP regulations, including:

- Failure to establish laboratory controls with scientifically sound specifications, standards, and test procedures to ensure compliance with identity, strength, quality, and purity standards (21 CFR 211.160(b)).

- Lack of an adequate quality control unit with the authority to approve or reject all components, containers, closures, in-process materials, and drug products (21 CFR 211.22(a)).

The FDA noted deficiencies in implementing appropriate release specifications and analytical procedures for some drug products. The Warning Letter calls for extensive remediation and CAPA measures and recommends hiring a CGMP consultant. The FDA may reject new drug manufacturing applications until all issues are resolved and compliance is confirmed through further inspections.