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1022105

Navinta, LLC — FEI 3004375014

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 18, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Postmarket Surv. and Epidemiology
Location
Ewing, NJ (United States)

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))
  • 971010 (OAI Mon May 16 2016 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
1802521 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683321 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
684221 CFR 314.80(j)Failure to maintain records