Linghai ZhanWang Biotechnology Co., Ltd received a warning letter from FDA

This Warning Letter highlights significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

Following a review of records provided under section 704(a)(4) of the FD&C Act, the following violations were identified:

1. Failure to test drug components for identity, purity, strength, and quality (21 CFR 211.84(d)(1) & (2)).
2. Lack of a stability testing program to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
3. Deficient quality control unit lacking authority to approve or reject materials and drug products (21 CFR 211.22(a)).

Due to these deficiencies, the drug products are considered adulterated under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).

11-03-2025

• Pharma GMP
• Food GMP
• Clinical Research
• Medical Device
• Environmental Health and Safety
• Healthcare
• Nutrition