FDA Inspection 760152 — Acclarent, Inc.
The FDA completed an inspection of Acclarent, Inc. on Feb 24, 2012 in Irvine, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 24, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |