Daito Pharmaceutical Co., Ltd.September 16, 2022

FDA 483 - Daito Pharmaceutical Co., Ltd. - September 16, 2022

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Record Details

Daito Pharmaceutical Co., Ltd. in Toyama City, Japan, was inspected by the FDA from September 12-16, 2022. The inspection revealed two significant issues related to quality control unit procedures and the handling of investigations into unexplained discrepancies. These observations indicate deficiencies in the firm's quality management system.

Company: Daito Pharmaceutical Co., Ltd.
Inspection Date: September 16, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Santiago Gallardo Johnson (https://www.fda.gov/media/120628/download)

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ID · 43e3bd6c-533d-44a9-8a0a-25124a4a7827