# FDA 483 - CIMBAR PERFORMANCE MINERALS, INC. - July 18, 2025

Source: https://www.keypedia.com/records/483/cimbar-performance-minerals-inc/3018ff6f-b073-4fa9-b29c-2744b6c5634a

> FDA 483 for CIMBAR PERFORMANCE MINERALS, INC. on July 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CIMBAR PERFORMANCE MINERALS, INC.
- Inspection Date: 2025-07-18
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: CIMBAR PERFORMANCE MINERALS, INC. in Chatsworth, GA, an API manufacturer, was inspected and received a Form 483 with two observations. The inspection revealed significant issues with process control, specifically deviations from validated manufacturing procedures that were not documented or justified. Additionally, the firm failed to thoroughly investigate unexplained discrepancies and batch failures to meet specifications, releasing non-conforming products based on inadequate justifications.

## Related Officers

- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)

Company: https://www.keypedia.com/companies/cimbar-performance-minerals-inc/de097cdd-af46-4d14-8566-45a6205d9895

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7