FDA Inspection 952969 — Blue Ortho
The FDA completed an inspection of Blue Ortho on Dec 17, 2015 in Meylan. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 17, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Meylan (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |