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Warning Letter

Case 613385 — FEI 3006271438

Facility

Recent inspections

  • 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))

Action Details

Facility
Novel Laboratories, Inc. d.b.a Lupin Somerset
Date
June 11, 2021
Fiscal Year
2021
Product Type
Drugs
Center
CDER
Location
Somerset, NJ (United States)