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981568

Teva Branded Pharmaceutical Products R&D — FEI 3004442422

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 30, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Horsham, PA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1065622 (NAI Fri Aug 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 816199 (VAI Wed Jan 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 703038 (NAI Thu Dec 02 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 665436 (VAI Wed May 19 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 611034 (NAI Fri Jul 31 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
357021 CFR 211.100(a)Approval and review of procedures
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports
8938FDCA 760(c)(1)Timing of AE report submission (non-RX drugs)