FDA 483 - Children's Hospital - June 13, 2025

Manning Family Children's in New Orleans, LA, an HCT/P and Blood Bank, was cited with two observations during an FDA inspection. The firm failed to validate critical cord blood processing methods, including those intended to prevent communicable disease transmission and ensure disinfectant efficacy. Additionally, the firm did not meet specified in-process control requirements, with documentation discrepancies noted regarding cord blood unit processing.