FDA 483 - NuVida Medical LLC - February 19, 2025

An FDA inspection of NuVida Medical LLC, an HCT/P warehouse and distributor in Phoenix, AZ, revealed significant deficiencies in record-keeping and adherence to established procedures. Observations included failure to maintain storage temperature records for allografts, lack of documentation for incoming HCT/P acceptance criteria to prevent communicable disease transmission, and insufficient 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.