# FDA 483 - Forthright Medical AZ LLC - February 19, 2025

Source: https://www.keypedia.com/records/483/forthright-medical-az-llc/03fb5487-6293-4149-96e7-c06a49399a04

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

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## Details

- Record Type: 483
- Company Name: Forthright Medical AZ LLC
- Inspection Date: 2025-02-19
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Forthright Medical AZ LLC, an HCT/P warehouse and distributor in Phoenix, AZ, revealed significant deficiencies in record-keeping and adherence to established procedures. The firm failed to maintain temperature records for stored allografts and birth tissue-derived products, did not follow pre-established criteria for accepting incoming HCT/Ps to prevent communicable disease transmission, and lacked proper 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 Documents

- [483 - 2025-02-19](https://www.keypedia.com/records/483/forthright-medical-az-llc/ee5f07a3-bcd5-4e07-b4b6-45d2f778e3c4)

## Related Officers

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

Company: https://www.keypedia.com/companies/forthright-medical-az-llc/23aba8b7-bcbd-44b6-901d-51b45c8a0aed

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6