FDA 483 - Pur Biologics, LLC - December 04, 2025

Pur Biologics, LLC, an HCT/P storage and distribution firm in Irvine, CA, was cited for significant deficiencies related to temperature monitoring and record-keeping during an FDA inspection. Observations included a failure to periodically review recorded storage temperatures and a lack of complete temperature records for human cell and tissue products. These issues indicate inadequate control over environmental conditions critical for HCT/P integrity.