Circulatory Technology Inc. – FDA Inspection, Jul 8, 2016

Record Details

This FDA Inspection record concerns Circulatory Technology Inc., with an inspection on July 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: Circulatory Technology Inc.
Inspection Date: July 8, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 19e82568-9f45-4f7b-9bd5-0ec8434db282

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 976745
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.30(g)Design validation acceptance criteria
21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 803.18(e)MDR not evaluated per 820.198
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 820.86Acceptance status
21 CFR 820.30(j)Design history file
21 CFR 820.30(e)Design review - documentation
21 CFR 820.50(a)(1)Documented evaluation

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Other FDA inspections of Circulatory Technology Inc.

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 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