FDA WARNING_LETTER - Zhejiang Huahai Pharmaceutical Co., Ltd. - January 24, 2025

On June 6, 2025, the FDA issued a Warning Letter to Zhejiang Huahai Pharmaceutical Co., Ltd. following an inspection from January 16-24, 2025, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Equipment Cleaning (21 CFR 211.67(a)):** Residue, including multiple active ingredients, was found on non-dedicated manufacturing equipment surfaces documented as cleaned. The firm's risk assessment and proposed cleaning procedure revisions were deemed inadequate, failing to scientifically demonstrate products are free of contaminants or assess microbial contamination. 2. **Aseptic Processing Area Control Deficiencies (21 CFR 211.42(c)(10)):** A 2cm x 126cm piece of non-sterile tape was observed in an ISO 5 (Grade A) aseptic area, used to facilitate cleaning between unsecure HEPA filters, without Quality Unit approval. The firm's response lacked comprehensive evaluation of the Quality Unit's role in facility modifications. 3. **Insufficient Production and Process Control Procedures (21 CFR 211.100(a)):** The firm lacked validation data for tablet compression reject limits for U.S. marketed products, relying on "prior manufacturing experience." A complaint for dissolution failure was attributed to high