Chugai Pharma Manufacturing Co. Ltd.February 21, 2020

FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - February 21, 2020

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Record Details

Chugai Pharma Manufacturing Co. Ltd in Utsunomiya, Japan, a drug product manufacturer, was cited for significant deficiencies in its manufacturing processes. The inspection revealed failures to establish and follow appropriate procedures to prevent microbiological contamination of sterile drug products, specifically concerning aseptic and sterilization process validation. Additionally, the firm's test methods were found to be inadequately validated or verified.

Company: Chugai Pharma Manufacturing Co. Ltd.
Inspection Date: February 21, 2020
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Zhihao Peter Qiu (issuing_officer)

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ID · 6d845505-2d19-4be5-b738-c8af14de1380