FDA WARNING_LETTER - Linghai ZhanWang Biotechnology Co., Ltd - February 10, 2025

The FDA issued a Warning Letter to Linghai ZhanWang Biotechnology Co., Ltd. (FEI 3015248821) on February 25, 2025, following a review of records submitted in response to a Section 704(a)(4) request. The facility, an OTC drug manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated.

Key violations include: 1. **Failure to test components:** The firm did not adequately test components like ethanol for methanol content, or glycerin and other components for diethylene glycol (DEG) and ethylene glycol (EG), violating 21 CFR 211.84(d)(1) and 211.84(d)(2). 2. **Inadequate stability program:** The firm lacked a sufficient stability program for OTC anti-microbial wipes, using unscientifically justified "accelerated aging experiments" and failing to conduct long-term stability studies to support labeled expiration dates, violating 21 CFR 211.166(a). 3. **Ineffective Quality Control Unit:** The Quality Unit (QU) failed to adequately oversee OTC drug manufacturing operations and exercise its authority to approve or reject materials and products, violating 21 CFR 211.22(a).

As a result, all drugs from the