FDA Inspection 1054398 — SPS Pharma Services
The FDA completed an inspection of SPS Pharma Services on May 29, 2018 in Orleans. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
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 |