FDA Inspection 1281428 — Corza Medical Distribution GmbH, Austria Branch
The FDA completed an inspection of Corza Medical Distribution GmbH, Austria Branch on Sep 12, 2025 in Linz. 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
- Sep 12, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Linz (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |