FDA Inspection 900868 — Fresenius Kabi Deutschland GmbH
The FDA completed an inspection of Fresenius Kabi Deutschland GmbH on Sep 26, 2014 in Friedberg (Hessen). 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 26, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Friedberg (Hessen) (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |