1067038
Laboratoris Feltor — FEI 3006306619
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 28, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Barcelona (Spain)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |