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1046857

Viatris Pharmaceuticals LLC — FEI 2627208

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 28, 2018
Fiscal Year
2018
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))
  • 1002319 (NAI Thu Dec 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935961 (VAI Thu Jul 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844978 (VAI Tue Aug 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
360321 CFR 211.160(b)Scientifically sound laboratory controls