FDA Inspection 809111 — Intersect ENT, Inc.
The FDA completed an inspection of Intersect ENT, Inc. on December 11, 2012 in Menlo Park, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 11, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Menlo Park, CA (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |