Astellas Pharma Inc.October 27, 2023

FDA 483 - Astellas Pharma Inc. - October 27, 2023

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Record Details

An FDA inspection of Astellas Pharma Inc. in Yaizu, Shizuoka, Japan, a drug manufacturer, revealed significant deficiencies in their complaint handling system. Specifically, market complaint records lacked scientifically sound justification for root causes, and investigations failed to include essential reviews such as batch, analytical data, and retain sample trending.

Company: Astellas Pharma Inc.
Inspection Date: October 27, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Michele Gottshall

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ID · b94c8cff-f872-4329-959e-7bc41db048a4