FDA Inspection
Novel Laboratories, Inc. d.b.a Lupin SomersetNovel Laboratories, Inc. d.b.a Lupin Somerset – FDA Inspection, Aug 26, 2013
Record Details
This FDA Inspection record concerns Novel Laboratories, Inc. d.b.a Lupin Somerset, with an inspection on August 26, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 26, 2013
- Product Type
- Drugs
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ID · 6b0b216c-08e8-45b7-91b4-140fc551b9b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 845686
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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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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