FDA 483 - Jiangxi Bioman Pharma Limited - July 30, 2022

An FDA inspection of Jiangxi Bioman Pharma Limited, an intermediate manufacturer in Shangrao, China, revealed significant deficiencies in their quality system. The firm failed to adequately follow quality unit procedures, including the proper classification and investigation of critical deviations. Additionally, the inspection found a lack of a scientifically sound cleaning validation program, raising concerns about potential cross-contamination.