Maquet Cardiovascular, LLC – FDA Inspection, Jun 14, 2012

Record Details

This FDA Inspection record concerns Maquet Cardiovascular, LLC, with an inspection on June 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Maquet Cardiovascular, LLC
Inspection Date: June 14, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · ac04fcd1-d77b-4ed8-8a44-a461028d9e88

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 778533
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(c)Process changes - review, evaluation and revalidation
21 CFR 820.198(d)Evaluation, timeliness, identification
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.25(a)Personnel
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
21 CFR 820.198(a)Lack of or inadequate complaint 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
April 1, 2011	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices