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984201

Nicklaus Children's Hospital — FEI 3000955478

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 3, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Miami, FL (United States)

Facility

Other inspections at this facility

  • 1253722 (NAI Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1198477 (NAI Thu Feb 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102551 (NAI Wed Aug 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 887839 (NAI Thu May 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 727131 (NAI Fri May 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1220321 CFR 606.170(a)Adverse Reaction- Reports of Investigations
1507621 CFR 610.46(b)(3)Notify MD, Legal Rep, or Relative of Transf Recip [Consign]
16621 CFR 606.170(a)Adverse reaction - Disposition of Reports
922521 CFR 606.171Biological product deviation report