FDA 483 - Second Pharma Co., Ltd. - August 30, 2024

An FDA inspection of Second Pharma Co., Ltd., an API manufacturer, revealed significant deficiencies in quality control. The firm failed to adequately monitor water for objectionable organisms, establish proper cleaning validation for shared manufacturing equipment, and thoroughly investigate out-of-specification results, including extending investigations to potentially affected batches. These issues indicate a lack of robust quality systems impacting product purity and safety.