FDA Inspection 749659 — LasikPlus Vision Center
The FDA completed an inspection of LasikPlus Vision Center on October 6, 2011 in Atlanta, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 6, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |
| 658 | 21 CFR 803.30(a)(2) | Report of Serious Injury Within 10 Days |