FDA Inspection 760152 — Acclarent, Inc.
The FDA completed an inspection of Acclarent, Inc. on February 24, 2012 in Irvine, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 24, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: 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 |