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

During an FDA inspection conducted from December 4-8, 2023, GFA Production Xiamen Co., Ltd., a non-sterile drug manufacturer, received a Form FDA 483 citing multiple significant violations of manufacturing and quality control regulations. The observations highlight systemic issues in data integrity, record-keeping, and process controls, which are fundamental to ensuring drug product quality and safety. Key issues identified include incomplete laboratory records, specifically undocumented analytical testing data from HPLC equipment with disabled audit trails, compromising data accuracy. Batch production records were found to be deficient, exhibiting inconsistencies, missing critical information, duplicate entries, and a lack of proper traceability for manufacturing activities and product quantities. The inspection also revealed inadequate procedures for preventing microbial contamination, characterized by poor aseptic techniques, lack of microorganism identification, visibly soiled laboratory equipment, and unverified sterilization processes. Furthermore, the company failed to maintain proper control over its equipment, with ignored system alarms, unverified disinfection systems, and disabled stability chamber alarms. There was an absence of essential process validations and cleaning re-validations for several drug products. The quality control unit did not consistently follow established procedures, exhibiting improper record-keeping practices and inadequate security for controlled documents and computer systems, including the ability to manipulate system dates and times without authorization. GFA Production Xiamen Co., Ltd. is required to address these serious observations by implementing comprehensive corrective actions to ensure compliance with Current Good Manufacturing Practices.