Atrium Medical Corporation – FDA Inspection, Oct 1, 2013

Record Details

This FDA Inspection record concerns Atrium Medical Corporation, with an inspection on October 1, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company: Atrium Medical Corporation
Inspection Date: October 1, 2013
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · f817aa00-23ba-474e-9843-b1e37909aa64

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 840237
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

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 820.198(a)Complaints
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.70(i)Software validation for automated processes

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Other FDA inspections of Atrium Medical Corporation

Date	Classification	Office	Project area
June 1, 2026	Not classified	New England District Office	Postmarket Assurance: Devices
November 26, 2024	NAI	New England District Office	Postmarket Assurance: Medical Devices
September 6, 2022	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
February 10, 2020	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 2, 2018	OAI	Center for Devices and Radiological Health	Project Evaluation: Devices