# FDA 483 - Buckeye International Inc - August 21, 2025

Source: https://www.globalkeysolutions.net/records/483/buckeye-international-inc/3a6803f4-fe77-4ca4-a5e1-7e7194800280

> FDA 483 for Buckeye International Inc on August 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Buckeye International Inc
- Inspection Date: 2025-08-21
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Buckeye International Inc. in Maryland Heights, MO, was inspected and cited for significant deficiencies in its drug manufacturing processes. The inspection revealed failures in component identity verification, laboratory controls, process validation, stability testing, and facility maintenance, indicating a systemic lack of adherence to quality standards. These issues collectively raise concerns about the identity, strength, purity, and quality of the drug products manufactured.

## Related Documents

- [483 - 2019-06-28](https://www.globalkeysolutions.net/records/483/buckeye-international-inc/799a1e7d-dd63-4c50-9ff7-8e3c13d9a7f6)
- [483 - 2021-06-04](https://www.globalkeysolutions.net/records/483/buckeye-international-inc/f885d4f8-19f2-4ae9-b046-8ccc51cf01b0)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/mary-l-schuckmann/fdbfffff-ef4b-49a2-8ea3-6254a600aaac)
- [Andrew J. Barrowcliff](https://www.globalkeysolutions.net/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)

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

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79