FDA Inspection 808572 — Nipro Vascular Innovations Americas Inc
The FDA completed an inspection of Nipro Vascular Innovations Americas Inc on Nov 15, 2012 in Bedford, MA. 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
- Nov 15, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bedford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |