# FDA 483 - Regen Suppliers LLC - December 16, 2025

Source: https://www.keypedia.com/records/483/regen-suppliers-llc/e05dfd0c-b7af-405f-bdfc-b06b8db196a3

> FDA 483 for Regen Suppliers LLC on December 16, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regen Suppliers LLC
- Inspection Date: 2025-12-16
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Regen Suppliers LLC, a biological product distributor in Scottsdale, AZ, was inspected by the FDA from November 17 to December 16, 2025. The inspection revealed significant deficiencies in quality control, complaint handling, donor eligibility determination, labeling, and distribution systems for their umbilical cord and umbilical cord blood products, including uninvestigated serious adverse events. The firm lacks established procedures and a functional quality control unit, indicating a severe lack of oversight and control over their distributed drug products.

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
- [Emily S. McGann](https://www.keypedia.com/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)
- [Garrad R. Poole](https://www.keypedia.com/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)

Company: https://www.keypedia.com/companies/regen-suppliers-llc/5aee5251-f9b1-4a67-a64c-3142f336900b

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