Maquet Cardiovascular, LLC – FDA Inspection, Sep 29, 2016

Record Details

This FDA Inspection record concerns Maquet Cardiovascular, LLC, with an inspection on September 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: Maquet Cardiovascular, LLC
Inspection Date: September 29, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 9d813dbb-f2b1-48be-bb62-4bb9b1c46a04

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 994785
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 803.56Submission of Supplement to Individual Report Within One Month
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.198(b)Review and evaluation for investigation
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures

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Other FDA inspections of Maquet Cardiovascular, LLC

Date	Classification	Office	Project area
July 11, 2024	OAI		Postmarket Assurance: Devices
February 26, 2021	VAI	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