Zevex, Inc. – FDA Inspection, Jul 30, 2015

Record Details

This FDA Inspection record concerns Zevex, Inc., with an inspection on July 30, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: Zevex, Inc.
Inspection Date: July 30, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · cf76a41c-57d6-4017-a8bb-bb1717cd5f73

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 938132
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.100(b)Documentation
21 CFR 820.30(f)Design verification - output does not meet input requirement
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.200(a)Servicing - Lack of or inadequate procedures

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Other FDA inspections of Zevex, Inc.

Date	Classification	Office	Project area
September 17, 2018	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
April 13, 2017	OAI	Center for Devices and Radiological Health	Compliance: Devices
August 30, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices
October 14, 2011	VAI	Center for Devices and Radiological Health	Compliance: Devices
December 29, 2010	OAI	Center for Devices and Radiological Health	Compliance: Devices