FDA Inspection
Concentric Medical IncConcentric Medical Inc – FDA Inspection, Nov 10, 2014
Record Details
This FDA Inspection record concerns Concentric Medical Inc, with an inspection on November 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Concentric Medical Inc
- Inspection Date
- November 10, 2014
- Product Type
- Devices
View Company Profile
ID · a33e1fd5-e5a9-4f73-8da2-335311ec542a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 902988
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.52(b)(4)Date of Report
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
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Other FDA inspections of Concentric Medical Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 16, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 30, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Concentric Medical Inc
- FDA Inspection 954209 - 2015-12-16
- FDA Inspection 671214 - 2010-06-30
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