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924691

Afton Scientific, LLC — FEI 1000123236

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 1, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Charlottesville, VA (United States)

Facility

Other inspections at this facility

  • 1237992 (VAI Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
189121 CFR 211.165(f)Failing drug products not rejected
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
360321 CFR 211.160(b)Scientifically sound laboratory controls