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829906

Vivus, Inc. — FEI 3000719979

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 26, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Campbell, CA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1218963 (NAI Fri Sep 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081231 (NAI Wed Nov 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 865709 (NAI Fri Jan 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 756318 (NAI Wed Nov 30 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports