483
Children's Hospital of Orange CountyChildren's Hospital of Orange County – FDA 483, Jan 16, 2024
Record Details
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.
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ID · 276ef377-4766-4ec5-82d8-971857807b03
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