FDA 483 - Regen Suppliers LLC - December 16, 2025

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.