FDA Inspection
All Dental Prodx, LLCAll Dental Prodx, LLC – FDA Inspection, Mar 23, 2018
Record Details
This FDA Inspection record concerns All Dental Prodx, LLC, with an inspection on March 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9d7788de-72b4-42f1-991a-ac4af8540c3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046789
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no 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
- 21 CFR 803.17Lack of Written MDR Procedures
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