FDA Inspection
LED Technologies, LLCLED Technologies, LLC – FDA Inspection, Apr 12, 2018
Record Details
This FDA Inspection record concerns LED Technologies, LLC, with an inspection on April 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a50c1dc1-219e-466b-9a65-6990291619ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048041
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LED Technologies, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 22, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LED Technologies, LLC
- FDA Inspection 981430 - 2016-06-30
- FDA Inspection 800774 - 2012-09-25
- FDA Inspection 579085 - 2009-04-22
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