FDA Inspection 780149 — OcuMetrics, Inc.
The FDA completed an inspection of OcuMetrics, Inc. on May 1, 2012 in Palo Alto, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 1, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Palo Alto, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3323 | 21 CFR 820.170(b) | Installer records |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |