FDA 483 - AVEM Labs LLC - May 21, 2025

AVEM Labs LLC, an HCT/P manufacturer in Las Vegas, NV, was inspected by the FDA from May 13-21, 2025. The inspection revealed significant deficiencies in manufacturing process validation, labeling accuracy, equipment calibration, record keeping for supplies, and retention of HCT/P records. These issues indicate a lack of adequate controls over critical aspects of HCT/P production and quality assurance.