483
Children's HospitalFDA 483 - Children's Hospital - June 13, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Person
Open in Dashboard
ID · 4e8e1c69-2260-4550-ad6c-7a9a8df2292a