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1086248

Jerome Stevens Pharmaceuticals, Inc. — FEI 2431950

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 11, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Bohemia, NY (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1247238 (NAI Thu Aug 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1171967 (VAI Wed Jun 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009653 (VAI Thu Mar 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935880 (VAI Thu Jul 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856030 (VAI Thu Nov 21 2013 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
683021 CFR 314.80(c)(2)Interval
683321 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report