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1008333

Biogen, Inc. — FEI 1220951

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 6, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Cambridge, MA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1190494 (NAI Fri Nov 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180550 (NAI Fri Sep 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1133055 (VAI Tue Nov 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1130379 (NAI Tue Sep 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046583 (NAI Tue Feb 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683221 CFR 314.80(c)(2)Late submission of annual safety reports