FDA Inspection
DENTSPLY Implants N.V.DENTSPLY Implants N.V. – FDA Inspection, Aug 31, 2017
Record Details
This FDA Inspection record concerns DENTSPLY Implants N.V., with an inspection on August 31, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Teresa K. Kastner
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ID · b7bf83d0-a641-4fd6-8065-03c36b906127
Inspection Facts
- Inspection number
- 1024009
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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