FDA 483 - Bushu Pharmaceuticals Ltd. - December 02, 2022

An FDA inspection of Bushu Pharmaceuticals Ltd. in Kawagoe, Japan, revealed significant deficiencies across its operations. The firm failed to adequately document and follow quality control unit procedures for complaints, deviations, and laboratory investigations. Additionally, established laboratory test procedures and facility control systems were found to be deficient, leading to concerns about data integrity, contamination prevention, and proper material segregation.