FDA Inspection 1306616 — Novel Laboratories, Inc.
The FDA completed an inspection of Novel Laboratories, Inc. on Apr 17, 2026 in Somerset, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 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 |