FDA 483 - Chugai Pharmaceutical Co., Ltd. - July 04, 2025

An FDA inspection of Chugai Pharma Manufacturing Co., Ltd. in Fujieda-City, Shizuoka, Japan, revealed two significant observations. The firm failed to thoroughly investigate unexplained discrepancies, specifically regarding metal contaminants in batches after changing investigation thresholds. Additionally, established microbial testing procedures were not followed, as air bubbles were observed in test plates during bioburden analysis.