FDA Inspection
Elixir Research LLCElixir Research LLC – FDA Inspection, Oct 11, 2012
Record Details
This FDA Inspection record concerns Elixir Research LLC, with an inspection on October 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elixir Research LLC
- Inspection Date
- October 11, 2012
- Product Type
- Devices
View Company Profile
ID · edefc6c2-91b6-449e-a325-c19f81098262
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803591
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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