FDA Inspection 947009 — Fresenius Kabi Austria GMBH
The FDA completed an inspection of Fresenius Kabi Austria GMBH on Jun 19, 2015 in Graz. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 19, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Graz (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |