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615049

Alkermes, Inc. — FEI 1000513229

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 29, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Waltham, MA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 933726 (NAI Thu May 28 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859795 (NAI Thu Dec 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 790639 (NAI Fri Jun 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
671021 CFR 310.305(c)(2)Submission of report follow-up
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report