FDA 483 - CIT Co., Ltd. - December 08, 2023

CIT Co., Ltd. in Tangjin, Chungnam, Korea, a drug manufacturer, was inspected by the FDA from December 4-8, 2023. The inspection revealed significant deficiencies across multiple areas, including inadequate computer controls, insufficient stability testing, unvalidated test methods, lack of cGMP training for personnel, and failure to test for objectionable microorganisms in drug products. These issues indicate a broad lack of adherence to current Good Manufacturing Practices for OTC drug products intended for the U.S. market.