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937344

Mylan Pharmaceuticals Inc. — FEI 3007886374

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 17, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Carlos, CA (United States)

Facility

Other inspections at this facility

  • 1132054 (NAI Tue Sep 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 990174 (NAI Fri Oct 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 894744 (NAI Thu Sep 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 799168 (NAI Thu Sep 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
191821 CFR 211.166(a)(2)Stability sample storage conditions described
192221 CFR 211.166(a)(4)Testing in same container - closure system
361321 CFR 211.160(b)(4)Establishment of calibration procedures
362921 CFR 211.170(b)Reserve samples identified, representative, stored
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies