FDA Inspection
Rocky Mountain OrthodonticsRocky Mountain Orthodontics – FDA Inspection, May 10, 2012
Record Details
This FDA Inspection record concerns Rocky Mountain Orthodontics, with an inspection on May 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rocky Mountain Orthodontics
- Inspection Date
- May 10, 2012
- Product Type
- Devices
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ID · 5d481261-14bb-4bb3-96e3-862d93b8e3f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781163
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 806.20(b)(4)Justification for not reporting
- 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 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rocky Mountain Orthodontics
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 26, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 5, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Rocky Mountain Orthodontics
- FDA Inspection 914564 - 2015-01-21
- FDA Inspection 741700 - 2011-08-26
- FDA Inspection 561896 - 2009-02-05
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