FDA Inspection 716018 — Optovue, Inc.
The FDA completed an inspection of Optovue, Inc. on April 7, 2011 in Fremont, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 7, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |