FDA Inspection 808572 — Infraredx, Inc.
The FDA completed an inspection of Infraredx, Inc. on November 15, 2012 in Bedford, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 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 |