Company
United StatesOssur Americas, Inc., Albion, MI – FDA Inspections
Inspection records and compliance data for Ossur Americas, Inc. in Albion, Michigan. 2 FDA inspections on record, last inspected November 21, 2014.
Company Profile
This profile covers Ossur Americas, Inc. based in Albion, Michigan, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 8, 2013. Last inspected November 21, 2014.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 904376 |
| February 8, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 817735 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ossur Americas, Inc.
FEI Number
3002440200
Address
910 Burstein Dr, Albion, Michigan 49224, United States
Country
United States
ID: 027e41ab-91a6-4602-815f-b2086c774f69