Maquet Cardiovascular, LLC – FDA Inspection, Oct 16, 2013

Record Details

This FDA Inspection record concerns Maquet Cardiovascular, LLC, with an inspection on October 16, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company: Maquet Cardiovascular, LLC
Inspection Date: October 16, 2013
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · a2cfe8f6-7a1a-4e10-b872-bdfeb24bf2b6

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 851685
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
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 820.40(a)Document review, approval by designated individual
21 CFR 820.198(d)Records of MDR Investigation
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(e)Design review - 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
September 29, 2016	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