Nippon Fine Chemical Co., Ltd.

FDA 483 - Nippon Fine Chemical Co., Ltd.

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Record Details

An FDA inspection of Nippon Fine Chemical Co., Ltd., an API Intermediate Manufacturer in Takasago City, Japan, revealed two significant observations. The firm failed to adequately extend investigations into rejected lots of API intermediate found with foreign matter. Additionally, the facility lacked adequate local exhaust ventilation systems in its packaging rooms, leading to visible powder accumulation.

Company: Nippon Fine Chemical Co., Ltd.
Product Type: Drugs
Office: Foreign - CDER (Non-Bioresearch Monitoring)
Person: Gavin T. Cua (issuing_officer)

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