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1071709

Novel Laboratories, Inc. d.b.a Lupin Somerset — FEI 3006271438

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 8, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Somerset, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1285934 (VAI Fri Oct 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1235495 (NAI Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1197049 (VAI Fri Jan 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168160 (VAI Wed Mar 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1133661 (OAI Thu Nov 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports
683221 CFR 314.80(c)(2)Late submission of annual safety reports
891221 CFR 314.81(b)(2)Timely submission