FDA Inspection 1222403 — Bavarian Nordic A/S
The FDA completed an inspection of Bavarian Nordic A/S on Nov 7, 2023 in Kvistgard. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 7, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Kvistgard (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |