FDA issued a Warning Letter to a Biotechnology Company in China

In April 2024, the FDA issued a Warning Letter to Jiangsu Meifan Biotechnology Co Ltd, a Chinese OTC drug manufacturer, citing significant Good Manufacturing Practice (CGMP) violations. The letter resulted from the FDA's review of documents submitted by the company in response to a request under the Federal Food, Drug, and Cosmetic Act. It highlighted issues such as insufficient laboratory testing of drug batches, especially regarding active ingredient identification and potency prior to release. Additionally, deficiencies in the company's quality control system, lacking proper oversight of drug manufacturing, were noted. Referencing the FDA's "Quality Systems Approach to Pharmaceutical CGMP Regulations" guidance, the letter recommended implementing a quality and risk management system.

To address these concerns, the FDA advised the company to hire a CGMP consultant, emphasizing that non-compliance could lead to further import restrictions and drug importation denial into the United States. Immediate corrective actions are urged to ensure compliance and prevent future problems. The full Warning Letter is accessible on the FDA website.