# FDA 483 - Buckeye International Inc - June 28, 2019

Source: https://www.globalkeysolutions.net/records/483/buckeye-international-inc/799a1e7d-dd63-4c50-9ff7-8e3c13d9a7f6

> FDA 483 for Buckeye International Inc on June 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Buckeye International Inc
- Inspection Date: 2019-06-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Buckeye International Inc, an OTC Human Drug Manufacturer in Maryland Heights, MO, was cited for multiple deficiencies in laboratory controls, production procedures, quality unit approvals, and complaint handling. Repeat observations included failure to investigate complaints, validate supplier COAs, and maintain sanitary building conditions. These findings indicate significant quality system issues at the facility.

## Related Documents

- [483 - 2021-06-04](https://www.globalkeysolutions.net/records/483/buckeye-international-inc/f885d4f8-19f2-4ae9-b046-8ccc51cf01b0)
- [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/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8