FDA Inspection
Image Plus Dental Design, LLCImage Plus Dental Design, LLC – FDA Inspection, Jan 4, 2013
Record Details
This FDA Inspection record concerns Image Plus Dental Design, LLC, with an inspection on January 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 4, 2013
- Product Type
- Devices
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ID · d301db5d-7d4c-4582-9ea9-6a3d461ded0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 812814
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(c)Management review dates
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