FDA 483 - Children's Hospital of Orange County - January 16, 2024

Children's Hospital of Orange County in Orange, CA, received a Form 483 following an inspection of its Blood Bank - Transfusion Services. The inspection revealed deficiencies in establishing and maintaining written standard operating procedures for blood component processing, particularly regarding documentation of operating conditions. Additionally, the firm failed to concurrently maintain records for significant processing steps, leading to discrepancies in record modification verification.