FDA 483 - LCC Ltd. - March 22, 2024

LCC Ltd., an OTC drug manufacturer in Eumseong, Korea, was cited for numerous significant deficiencies during an FDA inspection from March 18-22, 2024. The observations highlight severe issues across quality control, data integrity, personnel training, equipment management, and record-keeping, indicating a fundamental lack of adherence to cGMP. The firm demonstrated a pervasive failure to ensure the identity, strength, quality, and purity of its drug products.