FDA 483 - Abraham J. and Phyllis Katz Cord Blood Foundation - September 15, 2023

An FDA inspection of Abraham J. and Phyllis Katz Cord Blood Foundation in Warrensville Heights, OH, revealed significant deficiencies across multiple areas of their operations. Observations included inadequate aseptic processing area cleaning and environmental monitoring practices, as well as failures in maintaining concurrent records. These issues indicate a lack of adherence to established procedures and good documentation practices, which are critical for ensuring the quality and safety of cord blood units.