1066250
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farum (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 1845 | 21 CFR 211.84(d)(3) | Container/Closure Written Test Procedure |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |