FDA WARNING_LETTER - GFA Production Xiamen Co., Ltd. - December 08, 2023

The FDA inspected GFA Production Xiamen Co., Ltd. in Xiamen, China, from December 4-8, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's December 28, 2023, response to the Form FDA 483 was deemed inadequate. Key violations include the failure to establish and follow adequate written procedures for production and process control (21 CFR 211.100(a) and (b)), specifically citing a lack of process validation, inadequate cleaning validation, and insufficient equipment controls. Additionally, the firm failed to ensure laboratory records included complete data (21 CFR 211.194(a)), with in-house HPLC testing lacking audit trails and method validation. Lastly, the firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)), evidenced by inadequate microbiological methods and a failure to identify routinely observed microorganisms, which is critical given a prior recall for microbiological contamination. The FDA previously placed the firm on Import Alert 55-05 and subsequently on Import Alert 66-40. The firm committed to ceasing drug production at this facility and outsourcing manufacturing, but remains responsible for contract manufacturers. If manufacturing resumes, a qualified consultant and a comprehensive six-system audit are required. The firm must respond within 15 working days with corrective actions, including testing retain samples of all distributed batches within expiry. Failure to comply may result in continued refusal of admission of products and withholding of new application approvals.