FDA Inspection 906580 — Perouse Medical
The FDA completed an inspection of Perouse Medical on Dec 11, 2014 in Irigny. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 11, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irigny (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |