FDA 483 - Sichuan Huiyu Pharmaceutical Co., Ltd. - November 06, 2025

An FDA inspection of Sichuan Huiyu Pharmaceutical Co., Ltd. revealed significant deficiencies across its quality control, laboratory, and production systems. The firm failed to adequately investigate and reject potentially contaminated batches, maintain proper environmental monitoring, and ensure equipment sanitation. Additionally, there were systemic issues with complaint handling, OOS investigations, and the completeness of batch production records, indicating a broad lack of adherence to cGMP regulations.