794146
Weleda AG — FEI 1000326682
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Schwabisch Gmund (Germany)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |