FDA Inspection
Dental Evolutions, Inc.Dental Evolutions, Inc. – FDA Inspection, Jul 30, 2018
Record Details
This FDA Inspection record concerns Dental Evolutions, Inc., with an inspection on July 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · deb8258e-5086-403b-b8a2-5cb1a9de262e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061601
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Dental Evolutions, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 11, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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