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1285934

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

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 10, 2025
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Somerset, NJ (United States)

Facility

Other inspections at this facility

  • 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))
  • 1071709 (VAI Thu Nov 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures