Evologics, LLCJuly 27, 2021

FDA 483 - Evologics, LLC - July 27, 2021

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Record Details

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.

Company: Evologics, LLC
Inspection Date: July 27, 2021
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
Person: Richard T. Riggie (investigator)

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ID · ad19a201-8536-462b-bc66-2faf4c779e1b