FDA 483 - Forthright Medical AZ LLC - February 19, 2025

An FDA inspection of Forthright Medical AZ LLC, an HCT/P warehouse and distributor in Phoenix, AZ, revealed significant deficiencies in record-keeping and adherence to established procedures. The firm failed to maintain temperature records for stored allografts and birth tissue-derived products, did not follow pre-established criteria for accepting incoming HCT/Ps to prevent communicable disease transmission, and lacked proper documentation for HCT/P distribution activities. These issues indicate a lack of control over critical processes for human cells, tissues, and cellular and tissue-based products.