Angiodynamics Inc – FDA Inspection, May 28, 2014

Record Details

This FDA Inspection record concerns Angiodynamics Inc, with an inspection on May 28, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Angiodynamics Inc
Inspection Date: May 28, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 10d368b6-c525-4da7-b9f5-8ab4bb830c1c

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 882250
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(c)Design input - Lack of or inadequate procedures
21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.50(b)Approval, inadequate purchasing data

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Other FDA inspections of Angiodynamics Inc

Date	Classification	Office	Project area
September 26, 2018	Not classified	New England District Office
August 24, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 24, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices
February 13, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices
September 16, 2011	NAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act