FDA 483 - Bushu Pharmaceuticals Ltd. - December 02, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · b6765841-7334-4c55-a03f-48209c769b8e