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

An FDA inspection of Anhui Hanbon Daily Chemical Co., Ltd., an OTC manufacturer located in Huainan, Anhui, China, was conducted from February 24 to February 28, 2025. The inspection revealed several significant compliance issues concerning the company's quality, production, laboratory, and facilities systems.

Key violations include the absence of established written procedures for annual product reviews and inadequate production and process controls to ensure drug products meet required identity, strength, purity, and quality standards. Specifically, the company failed to conduct annual reviews for batches manufactured and distributed in the U.S. market from 2022 to 2023 and did not establish adequate procedures for consistent process controls for products distributed from 2022 to 2024.

Additionally, the firm did not validate test methods for chemical and microbial analysis of raw materials and finished products, leading to the use of non-validated methods for numerous batches. There was also a lack of identity testing for raw materials and excipients, and insufficient testing to determine appropriate expiration dates for products distributed between 2022 and 2024. The company also failed to conduct scientific-based stability studies to substantiate expiration dates.

The FDA requires Anhui Hanbon Daily Chemical Co., Ltd. to address these deficiencies by establishing proper procedures, validating test methods, and conducting necessary testing to ensure compliance with regulatory standards. The company is encouraged to discuss corrective actions with FDA representatives or submit a detailed response to the agency.