Maquet Cardiovascular, LLC – FDA Inspection, Feb 26, 2021

Record Details

This FDA Inspection record concerns Maquet Cardiovascular, LLC, with an inspection on February 26, 2021, issued by the Center for Devices and Radiological Health, covering devices.

Company: Maquet Cardiovascular, LLC
Inspection Date: February 26, 2021
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · cff9f6c1-d715-4610-977b-abc725450c87

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1136869
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.52(f)(1)Type of Reportable Event
21 CFR 803.56Submission of Supplement to Individual Report Within One Month
21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.30(g)Design validation - user needs and intended uses
21 CFR 820.25(b)Training records
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate

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Other FDA inspections of Maquet Cardiovascular, LLC

Date	Classification	Office	Project area
July 11, 2024	OAI		Postmarket Assurance: Devices
September 29, 2016	OAI	Center for Devices and Radiological Health	Compliance: Devices
October 16, 2013	OAI	Center for Devices and Radiological Health	Compliance: Devices
June 14, 2012	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
April 1, 2011	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices