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1129003

Alvogen, Inc — FEI 3008454186

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Morristown, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1230107 (NAI Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1144326 (VAI Thu Jun 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998487 (NAI Wed Jan 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 725081 (NAI Fri May 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683021 CFR 314.80(c)(2)Interval