FDA Inspection
MDPO, LLCMDPO, LLC – FDA Inspection, Oct 27, 2014
Record Details
This FDA Inspection record concerns MDPO, LLC, with an inspection on October 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MDPO, LLC
- Inspection Date
- October 27, 2014
- Product Type
- Devices
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ID · 5c8bedb4-516a-4c5c-8b59-1d28aadd60a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 902069
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 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 820.30(g)Design validation- 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
- 21 CFR 820.30(g)Design validation - Risk analysis
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