FDA Inspection 1298394 — CSL Behring GmbH
The FDA completed an inspection of CSL Behring GmbH on Feb 18, 2026 in Marburg. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 18, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Marburg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |