FDA Inspection
LaserSight Technologies, Inc.LaserSight Technologies, Inc. – FDA Inspection, Jan 21, 2009
Record Details
This FDA Inspection record concerns LaserSight Technologies, Inc., with an inspection on January 21, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 21, 2009
- Product Type
- Devices
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ID · ee2123c8-5bda-4dab-b08a-d5bb729f7412
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 562131
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.198(g)Foreign complaint files
- 21 CFR 820.198(a)General
- 21 CFR 820.25(a)Sufficient personnel
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.100(a)(1)Procedure for analysis of data sources
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Other FDA inspections of LaserSight Technologies, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 2, 2012 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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