Company
United StatesRocky Mountain Orthodontics, Franklin, IN – FDA Inspections
Inspection records and compliance data for Rocky Mountain Orthodontics in Franklin, Indiana. 4 FDA inspections on record (1 OAI), last inspected January 21, 2015.
Company Profile
This profile covers Rocky Mountain Orthodontics based in Franklin, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 5, 2009. Last inspected January 21, 2015.
Most cited issue areas
- Justification for not reporting2 inspections
- Lack of or inadequate process validation2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 21, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 914564 |
| May 10, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 781163 |
| August 26, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 741700 |
| February 5, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 561896 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Rocky Mountain Orthodontics
FEI Number
1718476
Address
2165 Earlywood Dr, Franklin, Indiana 46131, United States
Country
United States
ID: 334847f1-a2b4-4aaf-9817-3ca1fc66ab1e