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1022121

NYC Health + Hospitals/Bellevue — FEI 2473466

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 16, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1235880 (NAI Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168713 (VAI Fri May 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940685 (VAI Tue Sep 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 807822 (NAI Tue Nov 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 751621 (VAI Wed Nov 02 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1504521 CFR 610.47(b)(3)Notify MD, Legal Rep, Relative of Trans Recipient[Consignee]
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
900621 CFR 606.100(b)(19)Notification of attending physicians