1102946
Lusomedicamenta Sociedade Tecnica Farmaceutica S.A — FEI 3005491771
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Barcarena (Portugal)
Citations
| ID | CFR | Description |
|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |