FDA Inspection 562131 — LaserSight Technologies, Inc.
The FDA completed an inspection of LaserSight Technologies, Inc. on Jan 21, 2009 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 21, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Winter Park, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2403 | 21 CFR 820.25(a) | Sufficient personnel |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3383 | 21 CFR 820.198(g) | Foreign complaint files |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4189 | 21 CFR 820.198(a) | General |
| 537 | 21 CFR 820.70(a) | Production processes |