FDA Inspection
LED Intellectual Properties, LLCLED Intellectual Properties, LLC – FDA Inspection, Aug 2, 2018
Record Details
This FDA Inspection record concerns LED Intellectual Properties, LLC, with an inspection on August 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e5c26c76-38ab-4bac-9740-f7bb1c981221
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060880
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of LED Intellectual Properties, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 25, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 25, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LED Intellectual Properties, LLC
- FDA Inspection 973481 - 2016-05-09
- FDA Inspection 841479 - 2013-07-25
- FDA Inspection 709492 - 2011-01-25
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