Bushu Pharmaceuticals Ltd. – FDA 483, Aug 3, 2026

An FDA inspection of Bushu Pharmaceuticals Ltd. in Kawagoe, Japan, a drug manufacturer, revealed significant deficiencies in sample management and record-keeping. The firm failed to establish adequate written procedures for in-process controls and maintain complete laboratory records, leading to unaccounted excess samples and insufficient tracking of drug product units during testing. These issues indicate a lack of control over critical quality processes and data integrity.