# FDA 483 - Spartan Chemical Co Inc - November 21, 2025

Source: https://www.globalkeysolutions.net/records/483/spartan-chemical-co-inc/b5ecb519-51d5-4eca-99e9-609c01d0bef3

> FDA 483 for Spartan Chemical Co Inc on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spartan Chemical Co Inc
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Spartan Chemical Co Inc in Maumee, OH, revealed significant deficiencies in quality control and record-keeping practices. The firm failed to thoroughly investigate out-of-specification results and maintain adequate laboratory controls. Additionally, complaint handling procedures were found to be deficient, and master production records lacked required labeling documentation.

## Related Documents

- [483 - 2021-03-26](https://www.globalkeysolutions.net/records/483/spartan-chemical-co-inc/e7d405ff-f75f-4330-a807-7f9f2b484a14)
- [483 - 2022-12-12](https://www.globalkeysolutions.net/records/483/spartan-chemical-co-inc/2c927e03-debd-4374-859d-ffe90a1a652d)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)

Company: https://www.globalkeysolutions.net/companies/spartan-chemical-co-inc/96e5b21e-5d00-402a-a2ce-3c38c571a9b9

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22