# FDA 483 - Prime Matter Labs - September 01, 2023

Source: https://www.globalkeysolutions.net/records/483/prime-matter-labs/62f281a1-85e4-4963-92fe-71e4ca5dce9f

> FDA 483 for Prime Matter Labs on September 01, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Prime Matter Labs
- Inspection Date: 2023-09-01
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Prime Matter Labs in Hialeah, FL, was inspected and received a Form 483 with five observations highlighting significant deficiencies in their manufacturing operations. The inspection revealed issues with laboratory controls, facility maintenance, production process validation, reprocessing procedures, and the investigation of discrepancies. These findings indicate a lack of adherence to good manufacturing practices, potentially impacting the quality and purity of drug products.

## Related Officers

- [National Expert, Pharmaceutical](https://www.globalkeysolutions.net/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)
- [Program Coordinator](https://www.globalkeysolutions.net/people/martrice-a-packer/e9d89635-6323-4dc7-9222-c44cedcf46c2)

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

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6