# Prime Matter Labs – FDA 483, Jul 13, 2026

Source: https://www.keypedia.com/records/483/prime-matter-labs/1da8a806-e440-4677-ba26-0da3b58d4de5

> FDA 483 for Prime Matter Labs on July 13, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prime Matter Labs
- Inspection Date: 2026-07-13
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Prime Enterprises LLC, an OTC manufacturer in Hialeah, FL, revealed a significant issue regarding the identity testing of drug product components. The firm failed to perform complete identity testing on all incoming containers/lots of high-risk components, leading to the release of materials for manufacturing without adequate assurance of their identity or freedom from contamination. This lapse in quality control is a serious concern for drug product safety and efficacy.

## Related Documents

- [483 - 2023-09-01](https://www.keypedia.com/records/483/prime-matter-labs/62f281a1-85e4-4963-92fe-71e4ca5dce9f) — date: September 1, 2023

## Related Officers

- [Mickell Smith](https://www.keypedia.com/people/mickell-smith/ef92e41a-a16b-488a-a217-b10b54bb4f73)

Company: https://www.keypedia.com/companies/prime-matter-labs/dddd6753-e267-4dbe-af3e-69350e9aab1c

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9