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990477

Viatris Pharmaceuticals LLC — FEI 2623619

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 26, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Vega Baja, PR (United States)

Facility

Other inspections at this facility

  • 1162864 (VAI Thu Feb 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1038692 (VAI Fri Jan 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933988 (VAI Fri Jun 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871101 (VAI Tue Mar 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 840930 (VAI Tue Jul 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
180921 CFR 211.160(a)Following/documenting laboratory controls
440221 CFR 211.192Written record of investigation incomplete