FDA Inspection 1306616 — Novel Laboratories, Inc. d.b.a Lupin Somerset
The FDA completed an inspection of Novel Laboratories, Inc. d.b.a Lupin Somerset on April 17, 2026 in Somerset, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 17, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |