FDA 483 - GFA Production Xiamen Co., Ltd. - December 08, 2023

GFA Production Xiamen Co., Ltd., a non-sterile drug manufacturer in Xiamen, China, was cited for numerous deficiencies during an FDA inspection. The observations highlight significant data integrity issues, including undocumented testing and disabled audit trails, alongside widespread failures in batch record completeness and control. Further concerns include inadequate microbial control procedures, lack of equipment maintenance, and absence of critical process and cleaning validations, indicating a systemic breakdown in quality assurance.