960408
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cerdanyola Del Valles (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |