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761230

Lupin Pharmaceuticals Inc. — FEI 3004097115

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 23, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Naples, FL (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 880292 (VAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 718224 (NAI Wed Apr 06 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 572735 (NAI Fri Feb 27 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports
891221 CFR 314.81(b)(2)Timely submission