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971010

Navinta, LLC — FEI 3004375014

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 16, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Ewing, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1252822 (NAI Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1205480 (NAI Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1084188 (VAI Thu Mar 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022105 (VAI Fri Aug 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 937748 (NAI Mon Aug 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
683021 CFR 314.80(c)(2)Interval
891221 CFR 314.81(b)(2)Timely submission