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

During an inspection from September 18-21, 2023, the FDA identified significant compliance issues at Atlas Medical Holdings Inc., a storage distributor located in San Antonio, TX. The inspection revealed critical lapses in the company's operations concerning Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

Primary violations included the lack of documented inspection for incoming HCT/Ps, specifically OcuGraft amniotic membrane patches, to check for damage and contamination. The company's standard operating procedures did not outline this essential inspection process, and no records existed for numerous units received and shipped since May 2023. Additionally, Atlas Medical Holdings Inc. failed to establish a comprehensive quality program addressing core Current Good Tissue Practice (CGTP) requirements. This included the absence of a system to investigate and document deviations or adverse reactions related to CGTPs, and no process for reviewing and approving existing procedures. These observations indicate a need for prompt corrective actions to ensure compliance with regulatory standards aimed at preventing disease transmission through HCT/Ps.