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1062808

Maimonides Medical Center — FEI 2473845

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 20, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Brooklyn, NY (United States)

Facility

Other inspections at this facility

  • 1246405 (VAI Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 962633 (NAI Fri Mar 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874907 (NAI Mon Apr 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 795759 (VAI Fri Aug 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 685252 (VAI Thu Oct 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
14421 CFR 606.140(c)Adequate identification and handling of test samples
15421 CFR 606.160(a)(1)Concurrent documentation
24121 CFR 640.11(b)General requirements - inspection
25121 CFR 640.25(b)Quality control
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs