FDA Inspection
Light Emitting Designs, IncLight Emitting Designs, Inc – FDA Inspection, Mar 10, 2011
Record Details
This FDA Inspection record concerns Light Emitting Designs, Inc, with an inspection on March 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Light Emitting Designs, Inc
- Inspection Date
- March 10, 2011
- Product Type
- Devices
View Company Profile
ID · 620c66ec-ff35-452d-bab0-06ed1e3868ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 713525
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
17- 21 CFR 820.40Lack of procedures, or not maintained
- 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 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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