Company
United StatesOssur Americas, Foothill Ranch, CA – FDA Inspections
Inspection records and compliance data for Ossur Americas in Foothill Ranch, California. 6 FDA inspections on record, last inspected July 17, 2018.
Company Profile
This profile covers Ossur Americas based in Foothill Ranch, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected December 8, 2008. Last inspected July 17, 2018.
Most cited issue areas
- Equipment control activity documentation1 inspection
- Report of Death or Serious Injury1 inspection
- Submission of Supplement to Individual Report Within One Month1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 17, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1063083 |
| September 27, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 986687 |
| August 21, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 897335 |
| November 19, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 808387 |
| September 7, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 679074 |
| December 8, 2008 | NAI | Medical Devices & Rad Health · Compliance: Devices | 552662 |
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
Ossur Americas
FEI Number
1000519909
Address
27051 Towne Centre Dr, Foothill Ranch, California 92610, United States
Country
United States
ID: b99321db-aa98-4f20-aa2a-56979ac09053