FDA Inspection
Novel Laboratories, Inc. d.b.a Lupin SomersetNovel Laboratories, Inc. d.b.a Lupin Somerset – FDA Inspection, Nov 8, 2018
Record Details
This FDA Inspection record concerns Novel Laboratories, Inc. d.b.a Lupin Somerset, with an inspection on November 8, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 8, 2018
- Product Type
- Drugs
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ID · ced7bfaf-e380-44a1-a2f7-e88bb5dd55b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071709
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
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Other FDA inspections of Novel Laboratories, Inc. d.b.a Lupin Somerset
18| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2026 | Not classified | New Jersey District Office | Drug Quality Assurance |
| October 10, 2025 | VAI | New Jersey District Office | Compliance: Medical Devices |
| January 31, 2025 | Not classified | New Jersey District Office | |
| May 17, 2024 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| January 13, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Novel Laboratories, Inc. d.b.a Lupin Somerset
- FDA Inspection 1306616 - 2026-04-17
- FDA Inspection 1285934 - 2025-10-10
- FDA Inspection 1259938 - 2025-01-31
- FDA Inspection 1235495 - 2024-05-17
- FDA Inspection 1197049 - 2023-01-13
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