FDA 483 - AVEM Medical LLC - May 18, 2023

An FDA inspection of AVEM Medical LLC, an HCT/P distributor in Irving, TX, revealed significant deficiencies in temperature control for both drug products and human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm was cited for storing products outside specified temperature ranges for extended periods and failing to maintain adequate calibration records for monitoring equipment. These issues raise concerns about the identity, strength, quality, and purity of distributed products.