Maquet Cardiovascular, LLC – FDA Inspection, Apr 1, 2011

Record Details

This FDA Inspection record concerns Maquet Cardiovascular, LLC, with an inspection on April 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Maquet Cardiovascular, LLC
Inspection Date: April 1, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · f1dd5209-7a8e-4dfe-afb7-2bbc1ce6cfcb

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 715434
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.30(g)Design validation acceptance criteria
21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.75(c)Process changes - review, evaluation and revalidation
21 CFR 820.198(d)Evaluation, timeliness, identification
21 CFR 820.30(g)Design validation - user needs and intended uses
21 CFR 820.25(a)Personnel
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - 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
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