FDA Inspection
Vivos Therapeutics, Inc.Vivos Therapeutics, Inc. – FDA Inspection, Sep 11, 2017
Record Details
This FDA Inspection record concerns Vivos Therapeutics, Inc., with an inspection on September 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d556fcb5-c0d6-4307-8206-7a6d791fc4b9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1024832
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.40Lack of procedures, or not maintained
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Other FDA inspections of Vivos Therapeutics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 29, 2018 | Not classified | Denver District Office | Compliance: Devices |
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