483
Mitsubishi Tanabe Pharma Factory Ltd.Mitsubishi Tanabe Pharma Factory Ltd. – FDA 483, Jan 15, 2024
Record Details
An FDA inspection of Mitsubishi Tanabe Pharma Factory Ltd. in Yamaguchi, Japan, an API manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate cleaning validation for shared equipment, insufficient laboratory controls for related substance testing, and poor procedures for material storage. Additionally, the firm failed to thoroughly investigate unexplained discrepancies and lacked proper controls for electronic data and audit trails.
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ID · 51123db9-4aad-46fc-a971-b2854e552dd8
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