# FDA 483 - NuVida Medical LLC - February 19, 2025

Source: https://www.globalkeysolutions.net/records/483/nuvida-medical-llc/6aa0d58e-f4fe-465d-8b33-8d38852a0a07

> FDA 483 for NuVida Medical LLC on February 19, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NuVida Medical LLC
- Inspection Date: 2025-02-19
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of NuVida Medical LLC, an HCT/P warehouse and distributor in Phoenix, AZ, revealed significant deficiencies in record-keeping and adherence to established procedures. Observations included failure to maintain storage temperature records for allografts, lack of documentation for incoming HCT/P acceptance criteria to prevent communicable disease transmission, and insufficient documentation for HCT/P distribution activities. These issues indicate a lack of control over critical processes for human cells, tissues, and cellular and tissue-based products.

## Related Officers

- [Garrad R. Poole](https://www.globalkeysolutions.net/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)

Company: https://www.globalkeysolutions.net/companies/nuvida-medical-llc/fae26c37-dc70-4e3f-a914-0bbfda46376f

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face