FDA 483 - FirstCham Co., Ltd. - October 27, 2023

First Cham Co., Ltd., a drug and cosmetic manufacturer in Eumseong, Korea, was inspected by the FDA from October 23-27, 2023. The inspection revealed significant deficiencies across quality control, data integrity, validation, and manufacturing processes, including the distribution of out-of-specification drug products. These findings indicate a lack of adherence to cGMP requirements, posing potential risks to drug product quality and patient safety.