483
Chugai Pharmaceutical Co., Ltd.Chugai Pharmaceutical Co., Ltd. – FDA 483, Jul 4, 2025
Record Details
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.
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ID · 21a8b1f2-f960-4ae6-bb3e-6836197882ff
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