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

Source: https://www.keypedia.com/records/483/nippon-fine-chemical-co-ltd/c51d164b-18e2-4818-aa62-f84a1e19a0b2

> 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 Partnerships
- Summary: Nippon Fine Chemical Co., Ltd., an API Intermediate manufacturer in Takasago City, Japan, received a Form 483 for deficiencies in its quality system and facilities. The inspection revealed inadequate investigations into rejected lots for foreign matter and a lack of proper exhaust ventilation systems in packaging operations, leading to visible dust accumulation. These observations highlight concerns regarding product quality and environmental control.

## Related Documents

- [483 - 2019-06-11](https://www.keypedia.com/records/483/nippon-fine-chemical-co-ltd/de5dea24-ded0-4b35-acf8-f3f462ad6df9)
- [483 - 2025-11-14](https://www.keypedia.com/records/483/nippon-fine-chemical-co-ltd/43ec991a-8c6d-44a6-b32b-4079a51825f5)
- [483 - Unknown Date](https://www.keypedia.com/records/483/nippon-fine-chemical-co-ltd/ca521d5b-285e-4590-9a80-6b4236ef824b)

## 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-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3