Company
United StatesOsseon LLC, Santa Rosa, CA – FDA Inspections
Inspection records and compliance data for Osseon LLC in Santa Rosa, California. 4 FDA inspections on record, last inspected February 05, 2016.
Company Profile
This profile covers Osseon LLC based in Santa Rosa, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected September 15, 2009. Last inspected February 5, 2016.
Most cited issue areas
- Design validation - user needs and intended uses1 inspection
- Justification for not reporting1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 5, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 961500 |
| March 22, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 823242 |
| June 27, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 788278 |
| September 15, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 619894 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Osseon LLC
FEI Number
3007111981
Address
2301 Circadian Way Ste 300, Santa Rosa, California 95407, United States
Country
United States
ID: 9c163c3a-da2d-4324-9c68-518e23c55ce2