FDA 483 - Abraham J. and Phyllis Katz Cord Blood Foundation - January 17, 2020

The Abraham J & Phyllis Katz Cord Blood Foundation in Cleveland, OH, a licensed cord blood bank, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of written procedures for production controls, inadequate investigation of discrepancies, insufficient microbial control procedures, and deficiencies in aseptic processing areas and equipment maintenance. The firm also failed to maintain reserve samples and lacked proper procedures for component approval and storage.