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1025486

Bedford Research Foundation, Inc. — FEI 3005001384

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Bedford, MA (United States)

Facility

Other inspections at this facility

  • 1297208 (NAI Thu Dec 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216522 (NAI Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065596 (VAI Fri Sep 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878835 (NAI Thu May 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 750730 (NAI Tue Oct 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1221321 CFR 1271.47(a)Testing, screening, donor eligibility procedures
1223621 CFR 1271.55(a)(2)Eligibility statement--basis of determination
1224121 CFR 1271.55(b)(4)Reasons for ineligibility on summary
1227221 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
1227721 CFR 1271.75(a)(1)Risk factors, clinical evidence