FDA 483 - Anhui Hanbon Daily Chemical Co., Ltd. - February 28, 2025

An FDA inspection of Anhui Hanbon Daily Chemical Co., Ltd., an OTC manufacturer in Huainan, China, revealed significant deficiencies across its quality system, production, and laboratory controls. The firm failed to establish and follow adequate procedures for annual product reviews, process controls, test method validation, raw material identity testing, and stability studies. Additionally, laboratory equipment was not properly qualified or calibrated, indicating a severe lack of control over drug product quality.