FDA Inspection
Circulatory Technology Inc.Circulatory Technology Inc. – FDA Inspection, Jul 31, 2015
Record Details
This FDA Inspection record concerns Circulatory Technology Inc., with an inspection on July 31, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Circulatory Technology Inc.
- Inspection Date
- July 31, 2015
- Product Type
- Devices
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ID · 26255df7-a90d-487c-8c4b-972bf7b343b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 936945
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.30(e)Design review - documentation
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Other FDA inspections of Circulatory Technology Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 26, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 8, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 25, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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