FDA 483 - California Cryobank, Inc - August 07, 2009

An FDA inspection of California Cryobank, Inc. in Los Angeles, CA, a cord blood/stem cell processor, revealed significant deficiencies across multiple areas. The firm failed to validate critical processing procedures, ensure sterility of reagents, maintain an effective quality program, and adequately monitor environmental conditions. Additionally, issues were noted in donor eligibility screening and equipment cleaning protocols.