FDA 483 - LCC Ltd. - March 22, 2024

LCC Ltd., an OTC drug manufacturer in Eumseong, Korea, received 11 observations during an FDA inspection, highlighting severe deficiencies across its quality control unit, laboratory controls, and manufacturing processes. The firm failed to maintain raw data, conduct adequate stability studies, and provide requested records, indicating a fundamental lack of cGMP understanding among personnel. These issues collectively demonstrate a significant breakdown in ensuring drug product quality and safety.