FDA 483 - American CryoStem Corporation - May 22, 2024

An FDA inspection of American CryoStem Corporation in Monmouth Junction, NJ, revealed significant deficiencies in environmental controls for aseptic processing and the use of unverified or expired supplies. These issues raise concerns about the firm's ability to prevent the introduction and spread of communicable diseases during the processing of its ATgraft HCT/P products.