FDA Inspection 1093395 — Novo Nordisk Production Belgium SA
The FDA completed an inspection of Novo Nordisk Production Belgium SA on Jun 19, 2019 in Brussels. 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
- Jun 19, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Brussels (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |