FDA 483 - Jiangsu Alpha Pharmaceutical Co., Ltd. - January 25, 2019

An FDA inspection of Jiangsu Alpha Pharmaceutical Group, an intermediate manufacturer in Suqian City, China, revealed significant deficiencies in their manufacturing processes. Observations included incomplete master production records, unsanitary equipment conditions, improper storage and lack of cleaning records for transfer drums, inadequate out-of-specification (OOS) investigation procedures, and failures in stability testing methods and execution.