Zevex, Inc. – FDA Inspection, Dec 29, 2010

Record Details

This FDA Inspection record concerns Zevex, Inc., with an inspection on December 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Zevex, Inc.
Inspection Date: December 29, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · f466d57a-49df-47a1-9849-307210f7dc98

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 704438
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(b)(3)Conducting an Investigation
21 CFR 820.198(a)Complaints
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.100(b)Documentation
21 CFR 820.30(f)Design verification - output does not meet input requirement
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 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
July 30, 2015	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