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1237992

Afton Scientific, LLC — FEI 1000123236

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 8, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Charlottesville, VA (United States)

Facility

Other inspections at this facility

  • 1219743 (VAI Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1202143 (VAI Thu Apr 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1092986 (VAI Fri Jun 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025744 (VAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924691 (VAI Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
184621 CFR 211.84(d)(3)Establish reliability of supplier's C of A
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation