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

Aqualex Co., Ltd., a drug and cosmetic manufacturer in Seongnam-si, Korea, was cited for significant deficiencies in its quality control unit, laboratory controls, and documentation practices during an FDA inspection. Observations included unvalidated cleaning procedures, lack of stability testing, inadequate raw material sampling, and failure to maintain proper records for equipment cleaning and laboratory analyses. These issues indicate a systemic lack of adherence to Good Manufacturing Practices, posing a risk to drug product quality and integrity.