FDA WARNING_LETTER - Huons Co. Ltd - November 21, 2025

Huons Co., Ltd. received a warning letter from the FDA following an inspection from November 12 to 21, 2025, at its South Korean facility. The agency identified significant violations of Current Good Manufacturing Practice (CGMP) standards, which classifies the company’s drug products as adulterated under the Federal Food, Drug, and Cosmetic Act. The most critical issue involves widespread data integrity failures. Inspectors found that staff intentionally discarded failing test results, backdated records, and manipulated timestamps to conceal quality issues. Management even admitted to physically removing and replacing logbook pages to hide data discrepancies. Additionally, the company failed to conduct thorough investigations when products did not meet quality standards, often dismissing negative results without scientific justification. Concerns were also raised regarding sterile manufacturing processes. The FDA noted turbulent airflow in cleanrooms and poor employee behavior that risked contaminating products. Furthermore, protocols for disinfecting and monitoring equipment were found to be insufficient. As a result of these findings, Huons has suspended production for the U.S. market and initiated a voluntary product recall. To regain compliance, the FDA requires the company to hire independent consultants to oversee a comprehensive audit and data integrity investigation. Huons must also submit a detailed corrective action plan, perform a retrospective risk assessment on distributed drugs, and prove that their manufacturing design and quality oversight systems have been fully remediated.