# FDA 483 - Buckeye International Inc - June 04, 2021

Source: https://www.globalkeysolutions.net/records/483/buckeye-international-inc/f885d4f8-19f2-4ae9-b046-8ccc51cf01b0

> FDA 483 for Buckeye International Inc on June 04, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Buckeye International Inc
- Inspection Date: 2021-06-04
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Agnitio Inc. in Appleton, WI, was inspected by the FDA from June 1-4, 2021, and received a Form FDA 483. The inspection revealed that the firm failed to follow its written stability program, specifically regarding the review and verification of stability data for Triamterene Capsules 50 mg USP. This indicates a lapse in quality unit oversight concerning product stability.

## Related Documents

- [483 - 2019-06-28](https://www.globalkeysolutions.net/records/483/buckeye-international-inc/799a1e7d-dd63-4c50-9ff7-8e3c13d9a7f6)
- [483 - 2025-08-21](https://www.globalkeysolutions.net/records/483/buckeye-international-inc/3a6803f4-fe77-4ca4-a5e1-7e7194800280)

## Related Officers

- [Norman K. Starks](https://www.globalkeysolutions.net/people/norman-k-starks/4b8776e0-f96e-429c-94d1-40c0369f5378)

Company: https://www.globalkeysolutions.net/companies/buckeye-international-inc/01799cae-da24-4d86-9a28-d25a72c9bc8b

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669