FDA 483 - Evologics, LLC - July 27, 2021

Evologics, LLC, an HCT/Ps distributor in San Antonio, TX, was inspected by the FDA from July 21-27, 2021. The inspection revealed a significant issue with record-keeping practices, specifically concerning the concurrent documentation of returned human tissue products. This indicates a moderate severity issue related to quality control and compliance with regulatory requirements for tissue handling.