FDA Inspection 1231869 — Valneva Scotland Ltd.
The FDA completed an inspection of Valneva Scotland Ltd. on Mar 5, 2024 in Livingston. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 5, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Livingston (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |