FDA Inspection 945588 — Cousin Biotech SAS
The FDA completed an inspection of Cousin Biotech SAS on September 17, 2015 in Wervicq-Sud. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 17, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wervicq-Sud (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |