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1012796

Mylan Laboratories Limited (FDF-2) — FEI 3008316970

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 26, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chhatrapati Sambhajinagar (India)

Facility

Other inspections at this facility

  • 1253435 (VAI Fri Feb 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122884 (NAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091217 (NAI Fri Apr 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884211 (NAI Fri May 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 775616 (VAI Fri Mar 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
181021 CFR 211.160(a)Lab controls established, including changes
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications