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935961

Viatris Pharmaceuticals LLC — FEI 2627208

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 2, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Barceloneta, PR (United States)

Facility

Other inspections at this facility

  • 1273532 (NAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115559 (VAI Fri Dec 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046857 (VAI Wed Mar 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002319 (NAI Thu Dec 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844978 (VAI Tue Aug 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
180921 CFR 211.160(a)Following/documenting laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures