FDA Inspection
American Laser Healthcare CorpAmerican Laser Healthcare Corp – FDA Inspection, Jul 17, 2019
Record Details
This FDA Inspection record concerns American Laser Healthcare Corp, with an inspection on July 17, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff7d28ff-21e9-4e12-93cd-e93c3ed9215e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096783
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of American Laser Healthcare Corp
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for American Laser Healthcare Corp
- FDA Inspection 865962 - 2014-01-21
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