FDA Inspection
Oticon Medical AbOticon Medical Ab – FDA Inspection, Feb 20, 2014
Record Details
This FDA Inspection record concerns Oticon Medical Ab, with an inspection on February 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oticon Medical Ab
- Inspection Date
- February 20, 2014
- Product Type
- Devices
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ID · cfd0d3e2-cdbf-43ab-b76e-9139b91ed091
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867732
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Oticon Medical Ab
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2019 | Not classified | Office of Inspections and Investigations |
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