FDA Inspection 605402 — OcuMetrics, Inc.
The FDA completed an inspection of OcuMetrics, Inc. on August 18, 2009 in Palo Alto, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 18, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Palo Alto, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |