1178764
Laboratorios Cosmodent SL — FEI 3011042848
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 2, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- El Astillero (Spain)
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 |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |