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FDA Inspection 1050962 — Mylan Laboratories Limited

Mylan Laboratories Limited — FEI 3005587313

The FDA completed an inspection of Mylan Laboratories Limited on April 12, 2018 in Sinnar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 12, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sinnar (India)

Facility

Other inspections at this facility

  • 1117137 (NAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076887 (NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986244 (OAI Wed Sep 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920472 (VAI Wed Mar 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801056 (NAI Thu Aug 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources