FDA 483 - Lucina BioSciences, LLC - August 10, 2021

Lucina BioSciences, LLC in Aurora, CO, an HCT/P processor, was cited for significant deficiencies during an FDA inspection. Observations included failure to adequately screen HCT/P donors for communicable disease risk factors, inadequate environmental monitoring for microorganisms during processing, and insufficient record-keeping for processing steps and personnel. These issues indicate a lack of control over critical aspects of HCT/P manufacturing and donor eligibility.