FDA Inspection
Circulatory Technology Inc.Circulatory Technology Inc. – FDA Inspection, Sep 26, 2018
Record Details
This FDA Inspection record concerns Circulatory Technology Inc., with an inspection on September 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4a1befdc-86bf-4b39-bb97-1f84d55d005b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1067277
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.86Acceptance status
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(g)Design validation - 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 |
| July 8, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2015 | 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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