FDA Inspection 639717 — Optovue, Inc.
The FDA completed an inspection of Optovue, Inc. on January 8, 2010 in Fremont, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 8, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fremont, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 4189 | 21 CFR 820.198(a) | General |