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812545

Acorda Therapeutics, Inc. — FEI 3002457563

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 16, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Postmarket Surv. and Epidemiology
Location
Pearl River, NY (United States)

Facility

Other inspections at this facility

  • 1130049 (NAI Tue Aug 18 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100682 (NAI Fri Jul 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079179 (NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 975465 (VAI Mon Feb 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 892026 (VAI Mon Aug 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

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
673521 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events
682321 CFR 314.80(c)Failure by applicant to report ADE
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration