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986244

Mylan Laboratories Limited — FEI 3005587313

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 14, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Nasik, Nashik (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))
  • 1050962 (VAI Thu Apr 12 2018 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

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
1591821 CFR 111.95(a)Records - production, process control: electronic
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up