FDA 483 - AVEM Labs LLC - May 21, 2025

AVEM Labs LLC in Las Vegas, NV, an HCT/P manufacturer, was inspected by the FDA from May 13-21, 2025. The inspection revealed significant deficiencies across multiple areas, including unvalidated manufacturing processes for amniotic membrane products, inadequate labeling procedures, uncalibrated temperature monitoring equipment, and a failure to maintain essential records for supplies and HCT/Ps. These observations indicate a lack of robust quality control and record-keeping practices.