FDA Inspection 1082524 — Nova Laboratories Limited
The FDA completed an inspection of Nova Laboratories Limited on Mar 12, 2019 in Wigston. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Wigston (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |