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1171293

The A.R.T. Institute of Washington, Inc. — FEI 3003939193

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 8, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bethesda, MD (United States)

Facility

Other inspections at this facility

  • 1072158 (NAI Thu Oct 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945691 (NAI Tue Oct 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798982 (NAI Thu Sep 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 652899 (NAI Wed Mar 17 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1224421 CFR 1271.55(d)(1)(i)Documentation of CD testing and labs
1225221 CFR 1271.60(a)Completion of eligibility determination
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence
1228621 CFR 1271.80(b)Specimen collections not timely
1228721 CFR 1271.80(c)Kits not FDA approved, specifically labeled
1249221 CFR 1271.85(a)Infection with communicable disease agents