FDA Inspection
Ossur H / FOssur H / F – FDA Inspection, Jan 23, 2014
Record Details
This FDA Inspection record concerns Ossur H / F, with an inspection on January 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ossur H / F
- Inspection Date
- January 23, 2014
- Product Type
- Devices
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ID · d0c0f2bc-cf61-4837-a91d-c3ad34353e37
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866481
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(i)Documentation of software validation
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Other FDA inspections of Ossur H / F
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2018 | Not classified | Office of Inspections and Investigations | |
| August 17, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
Other documents for Ossur H / F
- FDA Inspection 1106568 - 2018-11-15
- FDA Inspection 1022620 - 2017-08-17
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