FDA Warning Letter: Inadequate Lab Testing Procedures

In August 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd." after having inspected its site in December 2023.

The significant violations of CGMP regulations for drug products, which are mentioned in the Warning Letter, are listed as follows:

• "Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). "
  
• "Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a))."

According to U.S. FDA Warning Letter, the firm failed to implement appropriate release specifications and analytical procedures in compliance with the US American CGMP requirements for some of their drug products.

The observed findings resulted in a long list of remediation activities and CAPA measurements requested.

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA recommends to engage a CGMP consultant. Additionally, the authority may refuse new applications listing the company as drug manufacturer until the site has addressed all observations and fully complies with CGMP requirements, which might be checked by a further inspection.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd.