# FDA 483 - Asahi Kasei Finechem Co., Ltd. - November 14, 2025

Source: https://www.globalkeysolutions.net/records/483/asahi-kasei-finechem-co-ltd/9195403b-6fee-4323-a607-c71d5c43e77d

> FDA 483 for Asahi Kasei Finechem Co., Ltd. on November 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asahi Kasei Finechem Co., Ltd.
- Inspection Date: 2025-11-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Asahi Kasei Finechem Co., Ltd. in Nobeoka, Japan, an API manufacturer, revealed a significant quality control issue. The firm failed to perform method validation studies on in-house developed test methods and method verification studies on USP methods used for finished product release testing. This deficiency compromises the firm's ability to ensure product quality and compliance with specifications.

## Related Documents

- [483 - 2025-11-10](https://www.globalkeysolutions.net/records/483/asahi-kasei-finechem-co-ltd/c7f97a01-c13b-4d2b-b819-00a8504a2fd2)

## Related Officers

- [Pharmacist | Consumer Safety Officer](https://www.globalkeysolutions.net/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.globalkeysolutions.net/companies/asahi-kasei-finechem-co-ltd/a6e157c7-1e20-4cf3-85d1-d9f64c58a6c0

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