# FDA 483 - Nippon Fine Chemical Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/nippon-fine-chemical-co-ltd/ca521d5b-285e-4590-9a80-6b4236ef824b

> FDA 483 for Nippon Fine Chemical Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nippon Fine Chemical Co., Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)

Company: https://www.keypedia.com/companies/nippon-fine-chemical-co-ltd/6b21c73b-4779-42c3-b0f6-64179f8de3a2

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1