FDA 483 - Kovas Co., Ltd. - November 29, 2024

Kovas Co., Ltd. in Paju-si, Gyeonggi-do, Korea, an OTC drug product manufacturer, was inspected by the FDA and found to have significant deficiencies. The inspection revealed inadequate controls over computer systems, unsound laboratory test methods, incomplete laboratory and batch production records, and failures in quality control unit responsibilities and equipment maintenance. These issues indicate a systemic lack of adherence to Good Manufacturing Practices, posing risks to the identity, strength, quality, and purity of drug products.