FDA Inspection
GAM Laser, Inc.GAM Laser, Inc. – FDA Inspection, Sep 25, 2018
Record Details
This FDA Inspection record concerns GAM Laser, Inc., with an inspection on September 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 70ddd0ee-a8c0-425e-b22d-6fe7d02429f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066862
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1040.10(h)(1)(i)User information, adequate instructions
- 21 CFR 1040.10(h)(1)(ii)User information, radiation output information
- 21 CFR 1040.10(h)(1)(iv)User info - list controls, etc.
- 21 CFR 1040.10(h)(2)(i)Reproduction of affixed information
- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.30(a)(2)Methods, devices, procedures for testing
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Other FDA inspections of GAM Laser, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2014 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| May 21, 2010 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for GAM Laser, Inc.
- FDA Inspection 894946 - 2014-09-11
- FDA Inspection 665445 - 2010-05-21
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