FDA Inspection
Illumination Technologies, LLCIllumination Technologies, LLC – FDA Inspection, Aug 5, 2016
Record Details
This FDA Inspection record concerns Illumination Technologies, LLC, with an inspection on August 5, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 5, 2016
- Product Type
- Devices
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ID · 0e5d293a-9db0-4cb3-9730-3df75b97e406
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982061
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Illumination Technologies, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Illumination Technologies, LLC
- FDA Inspection 621491 - 2009-09-10
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