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

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.