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590674

AssureImmune, LLC — FEI 3006813595

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 16, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Miami, FL (United States)

Facility

Other inspections at this facility

  • 1299120 (NAI Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121360 (NAI Wed Feb 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034907 (NAI Wed Nov 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 842553 (NAI Tue Jul 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1231121 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
1231221 CFR 1271.160(b)(2)Procedures for complaints and other information
1240521 CFR 1271.250(a)Controlling the labeling of HCT/Ps
1249021 CFR 1271.85(b)(1)Cell-associated CD