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840930

Viatris Pharmaceuticals LLC — FEI 2623619

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 16, 2013
Fiscal Year
2013
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))
  • 990477 (VAI Tue Jul 26 2016 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))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
191421 CFR 211.166(a)Lack of written stability program
191721 CFR 211.166(a)(1)Sample size - test intervals
361321 CFR 211.160(b)(4)Establishment of calibration procedures