FDA 483 - AVEM Labs LLC - November 22, 2022

AVEM LABS LLC, a stem cell manufacturer in Las Vegas, NV, was cited for multiple significant deficiencies during an FDA inspection from November 14-22, 2022. The observations primarily concern inadequate process validation, lack of stability data for expiration dates, insufficient aseptic process validation, poor record-keeping, and failures in donor eligibility determination and component control for their HCT/P products. These issues indicate a systemic lack of control over critical manufacturing and quality processes.