FDA Inspection
Novel Laboratories, Inc. d.b.a Lupin SomersetNovel Laboratories, Inc. d.b.a Lupin Somerset – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Novel Laboratories, Inc. d.b.a Lupin Somerset, with an inspection on December 21, 2018, issued by the New Jersey District Office, covering human drugs.
- Inspection Date
- December 21, 2018
- Product Type
- Human Drugs
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ID · ead9e8b8-cccf-4db5-83c0-b00f8ca238a9
Inspection Facts
- Inspection number
- 1075292
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
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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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