# FDA 483 - ProMED Concepts, LLC - March 03, 2025

Source: https://www.keypedia.com/records/483/promed-concepts-llc/cb08ce4a-d1c7-4ff9-b9c7-6922824648cd

> FDA 483 for ProMED Concepts, LLC on March 03, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ProMED Concepts, LLC
- Inspection Date: 2025-03-03
- Product Type: device
- Office Name: New Orleans District Office
- Summary: PROMED Concepts, LLC, a contract manufacturer in Brighton, TN, was inspected by the FDA from February 24 to March 3, 2025. The inspection revealed significant and repeat deficiencies in the firm's quality system, specifically regarding corrective and preventive action (CAPA) procedures and the handling of customer complaints. These issues indicate a systemic failure to adequately establish and maintain essential quality processes.

## Related Officers

- [Javelle P. Spann](https://www.keypedia.com/people/javelle-p-spann/31a8f7a8-e442-4f5a-b33f-55bfe911e61b)

Company: https://www.keypedia.com/companies/promed-concepts-llc/ff08d35f-4009-456f-b9fd-ac53839c7e23

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea