1054398
SPS Pharma Services — FEI 3009886271
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 29, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Orleans (France)
Citations
| ID | CFR | Description |
|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |