# FDA 483 - Nippon Rika Co., Ltd. - July 04, 2025

Source: https://www.globalkeysolutions.net/records/483/nippon-rika-co-ltd/b53cdb1c-381f-40b8-a176-cf1a0ef29ace

> FDA 483 for Nippon Rika Co., Ltd. on July 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nippon Rika Co., Ltd.
- Inspection Date: 2025-07-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Nippon Rika Co., Ltd. in Ashikaga, Japan, an API manufacturer, revealed seven significant observations. The firm was cited for deficiencies in stability testing method verification, inadequate control of quality control samples, and insufficient review of electronic laboratory data. Additionally, issues included poor computer system controls, an inadequate process validation program, incorrect batch record yield calculations, and a failure to thoroughly investigate discrepancies and implement preventive actions.

## Related Officers

- [Crystal Monroy](https://www.globalkeysolutions.net/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)

Company: https://www.globalkeysolutions.net/companies/nippon-rika-co-ltd/28d4ba43-fd16-42e5-9335-0a449b2f57eb

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8