FDA WARNING_LETTER - Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - November 07, 2025

The FDA issued a warning letter to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. following an inspection of its facility in Ezhou City, China, conducted from November 3 to 7, 2025. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) standards for active pharmaceutical ingredients (APIs), as defined under the Federal Food, Drug, and Cosmetic Act. The primary issues involved a failure to maintain manufacturing equipment properly. Specifically, investigators discovered scratches and stains on surfaces that come into contact with the product, suggesting that the equipment"s material is reacting with chemicals used in production. This poses a high risk of contaminating medicine with foreign particles. Additionally, the company’s Quality Unit failed to provide necessary oversight, neglecting to ensure that buildings were properly maintained and that equipment was suitable for its intended chemical processes. To address these deviations, the FDA requires the company to implement a comprehensive oversight plan for facility maintenance and conduct a retrospective quality review of all drug batches currently within their shelf life. The firm must also evaluate all manufacturing processes for material reactivity and provide a plan to empower its Quality Unit with better resources and authority. A formal response detailing these corrective steps is required within 15 working days. Failure to rectify these issues may lead to the FDA withholding drug approvals or refusing the entry of the company’s products into the United States.