FDA Inspection
Rocky Mountain OrthodonticsRocky Mountain Orthodontics – FDA Inspection, Aug 26, 2011
Record Details
This FDA Inspection record concerns Rocky Mountain Orthodontics, with an inspection on August 26, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rocky Mountain Orthodontics
- Inspection Date
- August 26, 2011
- Product Type
- Devices
View Company Profile
ID · b482453b-c11f-467f-b200-b04e3799bce0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 741700
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate 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 |
| May 10, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 781163 - 2012-05-10
- FDA Inspection 561896 - 2009-02-05
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