FDA Warning Letter to a Biotechnology Company in China

The FDA's new Warning Letter dated April 2024 identifies significant good manufacturing practice (CGMP) violations at Jiangsu Meifan Biotechnology Co Ltd, an over-the-counter (OTC) drug manufacturer in China. The authority's objections are based on a review of documents submitted by the company in response to a request from the FDA under the Federal Food, Drug and Cosmetic Act. The letter cites, among other things, inadequate laboratory testing of drug batches, particularly with respect to the identity and strength of active ingredients prior to product release. It also cites deficiencies in the company's quality control system, which failed to properly monitor drug manufacturing, and refers to the FDA's "Quality Systems Approach to Pharmaceutical CGMP Regulations" guidance as support for implementing a quality system and risk management system.

Finally, the FDA recommends hiring a CGMP consultant to help address these issues and warns that noncompliance may lead to further import restrictions and denial of importation of drugs into the United States. The letter emphasizes that these violations, as well as other non-listed violations, must be corrected immediately to ensure compliance and avoid future problems. Read the full Warning Letter on the FDA website.

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