FDA Inspection
Ossur Americas, Inc.Ossur Americas, Inc. – FDA Inspection, Nov 21, 2014
Record Details
This FDA Inspection record concerns Ossur Americas, Inc., with an inspection on November 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ossur Americas, Inc.
- Inspection Date
- November 21, 2014
- Product Type
- Devices
View Company Profile
ID · 14c89545-d981-4800-bc41-f86c3c30b7f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 904376
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of Ossur Americas, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ossur Americas, Inc.
- FDA Inspection 817735 - 2013-02-08
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