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1210327

Cincinnati Childrens Hospital Medical Center — FEI 3012688591

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 12, 2023
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Cincinnati, OH (United States)

Facility

Other inspections at this facility

  • 1260751 (NAI Wed Feb 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149625 (NAI Thu Aug 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079825 (NAI Thu Feb 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066736 (NAI Thu Sep 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992006 (NAI Tue Nov 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228721 CFR 1271.80(c)Kits not FDA approved, specifically labeled