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675139

Mount Sinai Hospital Blood Bank — FEI 2470025

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 17, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1243297 (VAI Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168200 (NAI Wed Apr 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046035 (NAI Wed Jan 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 950522 (NAI Thu Nov 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 889365 (NAI Mon Jul 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
154021 CFR 211.125(a)Strict control not exercised over labeling issued
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
22721 CFR 640.4(h)Storage temperatures after collection
8121 CFR 606.100(b)(2)Donor qualifying tests & measurements
922021 CFR 606.100(b)(21)Donor notification
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations