Home / Inspections / 1043498

1043498

Abbott Diagnostics Scarborough, Inc. — FEI 1221359

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 2, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Scarborough, ME (United States)

Facility

Other inspections at this facility

  • 1074516 (VAI Fri Nov 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979669 (NAI Fri Jul 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 820210 (NAI Fri Feb 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 725836 (NAI Fri May 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 598195 (VAI Fri Jul 17 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
63121 CFR 803.17(a)(1)Lack of System for Event Evaluations
73121 CFR 803.50(a)(1)Report of Death or Serious Injury
73221 CFR 803.50(a)(2)Individual Report of Malfunction