FDA 483 - ClinImmune Labs-Univ Colorado Cord Blood Bank and Stem Cell Lab

ClinImmune Labs, a cord blood manufacturer in Aurora, CO, was cited for significant deficiencies across its quality control, aseptic processing, and laboratory control systems. Observations included inadequate failure investigations, insufficient personnel training, flawed media fill studies, lack of environmental monitoring data review, and poor access controls for cleanrooms and computer systems. These issues indicate a systemic breakdown in ensuring product quality and safety.