FDA Inspection 765704 — LaserSight Technologies, Inc.
The FDA completed an inspection of LaserSight Technologies, Inc. on Feb 2, 2012 in Winter Park, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 2, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Winter Park, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5146 | 21 CFR 1040.10(f)(2)(iii)(a) | No multiple safety interlock |
| 5150 | 21 CFR 1040.10(f)(3) | Remote interlock connector |
| 5197 | 21 CFR 1040.10(h)(1)(i) | User information, adequate instructions |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |
| 5211 | 21 CFR 1040.11(b) | Surveying, leveling, alignment laser products |