1053840
Orion Corporation, Orion Pharma — FEI 3003073605
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Espoo (Finland)
Citations
| ID | CFR | Description |
|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2017 | 21 CFR 211.188(b)(5) | In-Process and Laboratory Control Results |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |