FDA Inspection
Novel Laboratories, Inc. d.b.a Lupin SomersetNovel Laboratories, Inc. d.b.a Lupin Somerset – FDA Inspection, Nov 5, 2020
Record Details
This FDA Inspection record concerns Novel Laboratories, Inc. d.b.a Lupin Somerset, with an inspection on November 5, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 5, 2020
- Product Type
- Drugs
View Company Profile
ID · d1fc9285-045e-4581-8571-b1a5c6599dc3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1133661
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
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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