Shionogi Pharma Co. Ltd.October 20, 2023

FDA 483 - Shionogi Pharma Co. Ltd. - October 20, 2023

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Record Details

Shionogi Pharma Co., Ltd. in Tokushima, Japan, was cited for significant deficiencies across its quality control and manufacturing processes. Observations included inadequate Out-of-Specification investigations, unvalidated analytical and cleaning methods, and insufficient laboratory controls. Additionally, the firm's water sampling practices were found to be unrepresentative, and microbial risk assessments were lacking.

Company: Shionogi Pharma Co. Ltd.
Inspection Date: October 20, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Lata C. Mathew

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ID · 7fdd5d6a-6207-489b-af21-6817f9d78a7a