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1092986

Afton Scientific, LLC — FEI 1000123236

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 14, 2019
Fiscal Year
2019
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))
  • 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
142121 CFR 211.42(c)(10)Aseptic Processing Area
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
434221 CFR 211.142(b)Storage under appropriate conditions
440421 CFR 211.194(a)(1)Sample identification and other information