876911
Hikma Farmaceutica, (Portugal) S.A. — FEI 3002807173
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 28, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Terrugem Snt (Portugal)
Citations
| ID | CFR | Description |
|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |