803791
Fareva Unterach GmbH — FEI 3002829723
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 23, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Unterach Am Attersee (Austria)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |