FDA Inspection
Medical Laser Systems IncMedical Laser Systems Inc – FDA Inspection, Dec 14, 2010
Record Details
This FDA Inspection record concerns Medical Laser Systems Inc, with an inspection on December 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medical Laser Systems Inc
- Inspection Date
- December 14, 2010
- Product Type
- Devices
View Company Profile
ID · 12ed86eb-5a49-4f23-a7d5-1c7200154807
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 700970
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.198(e)Records of complaint investigation
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Other FDA inspections of Medical Laser Systems Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 17, 2013 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Medical Laser Systems Inc
- FDA Inspection 970159 - 2016-05-11
- FDA Inspection 836812 - 2013-06-17
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