FDA 483 - Aqualex Co., Ltd. - October 20, 2023

An FDA inspection of Aqualex Co., Ltd., a drug and cosmetic manufacturer in Seongnam-si, Gyeonggi-do, Korea, was conducted from October 16-20, 2023. The inspection identified significant deviations from Good Manufacturing Practices (GMP), resulting in the issuance of a Form FDA 483. Key observations included a lack of written and adhered-to quality control procedures, specifically regarding cleaning validation, equipment qualification, and robust documentation practices where raw data was discarded without oversight. Laboratory controls were deemed inadequate, with no established stability testing program for drug products, insufficient microbial testing validation, and non-representative raw material sampling. Additionally, the purified water system contained defects and exhibited microbial excursions that went unaddressed. Critical cleaning records for manufacturing equipment were not maintained, highlighting systemic issues in documentation and quality assurance. These observations necessitate immediate and comprehensive corrective actions from Aqualex Co., Ltd. to ensure compliance with regulatory standards and safeguard product quality.