# FDA 483 - PRG Management LLC - February 14, 2025

Source: https://www.keypedia.com/records/483/prg-management-llc/20fa83ea-ac96-4aeb-8bdf-759889eb52ab

> FDA 483 for PRG Management LLC on February 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PRG Management LLC
- Inspection Date: 2025-02-14
- Product Type: device
- Office Name: Florida District Office
- Summary: PRG Management LLC, an initial importer and distributor in Miami, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked fundamental procedures and records for handling customer complaints and Medical Device Reports (MDRs), accepting incoming products, and evaluating suppliers. These issues indicate a severe absence of basic quality control processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/prg-management-llc/3a1d8a4b-6234-4204-a00e-d52eb19ec6a7

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