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886146

Mylan Teoranta — FEI 3002806521

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 27, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Inverin (Ireland)

Facility

Other inspections at this facility

  • 1202025 (VAI Fri Jul 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123541 (VAI Fri Jun 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1041657 (VAI Fri Feb 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978312 (NAI Wed Jun 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 782346 (NAI Fri Mar 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
181021 CFR 211.160(a)Lab controls established, including changes
189021 CFR 211.165(e)Test methods
358321 CFR 211.110(a)Written in-process control procedures
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration