Atlas Medical Holdings IncSeptember 21, 2023

FDA 483 - Atlas Medical Holdings Inc - September 21, 2023

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Record Details

Atlas Medical Holdings Inc, a storage distributor in San Antonio, TX, was inspected regarding its handling of HCT/Ps. The inspection revealed significant deficiencies, including a lack of documented inspection for incoming HCT/Ps like OcuGraft, and the absence of a comprehensive quality program to address core current good tissue practice (CGTP) requirements. These issues indicate a failure to ensure product quality and prevent the spread of communicable diseases.

Company: Atlas Medical Holdings Inc
Inspection Date: September 21, 2023
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
People: Bobbi Miller
Robert M. Tillman (investigator)

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ID · abdc4256-81fd-4765-8e68-c3d07567d7b7