FDA Inspection 820588 — Oculus Surgical, Inc.
The FDA completed an inspection of Oculus Surgical, Inc. on March 1, 2013 in Stuart, FL. 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
- March 1, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Stuart, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |