# FDA 483 - Nippon Protein Co., Ltd. Ashikaga Plant - June 27, 2025

Source: https://www.globalkeysolutions.net/records/483/nippon-protein-co-ltd-ashikaga-plant/634252ef-80f9-46ea-b6ce-40a925e2f8e3

> FDA 483 for Nippon Protein Co., Ltd. Ashikaga Plant on June 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nippon Protein Co., Ltd. Ashikaga Plant
- Inspection Date: 2025-06-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Nippon Protein Co., Ltd. Ashikaga Plant, an API manufacturer in Japan, received a Form 483 with three observations during an FDA inspection from June 23-27, 2025. The observations primarily concern failures in quality control systems, including inadequate investigations into discrepancies, lack of cleaning validation, and insufficient equipment qualification processes. These issues indicate a moderate level of concern regarding the firm's adherence to good manufacturing practices.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/nippon-protein-co-ltd-ashikaga-plant/ccd4e515-8d9e-4f63-9a5d-b117cf2659d6

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