FDA Inspection
Novel Laboratories, Inc. d.b.a Lupin SomersetNovel Laboratories, Inc. d.b.a Lupin Somerset – FDA Inspection, Apr 17, 2026
Record Details
This FDA Inspection record concerns Novel Laboratories, Inc. d.b.a Lupin Somerset, with an inspection on April 17, 2026, issued by the New Jersey District Office, covering human drugs.
- Inspection Date
- April 17, 2026
- Product Type
- Human Drugs
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ID · 3929d635-0f63-4a0a-b47f-d35102bc3d33
Inspection Facts
- Inspection number
- 1306616
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(b)Representative Samples Criteria
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Other FDA inspections of Novel Laboratories, Inc. d.b.a Lupin Somerset
18| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| March 30, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Novel Laboratories, Inc. d.b.a Lupin Somerset
- FDA Inspection 1285934 - 2025-10-10
- FDA Inspection 1259938 - 2025-01-31
- FDA Inspection 1235495 - 2024-05-17
- FDA Inspection 1197049 - 2023-01-13
- FDA Inspection 1168160 - 2022-03-30
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