Angiodynamics, Inc. – FDA Inspection, Feb 10, 2012

Record Details

This FDA Inspection record concerns Angiodynamics, Inc., with an inspection on February 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Angiodynamics, Inc.
Inspection Date: February 10, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · a2fd2ca5-5521-4f5a-9d70-a7df28aba1da

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 756504
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: 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 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.198(b)Review and evaluation for investigation
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.160(a)Lack of or inadequate procedures for distribution
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.120Lack of or inadequate procedures for labeling

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Other FDA inspections of Angiodynamics, Inc.

Date	Classification	Office	Project area
January 10, 2025	NAI	New York District Office	Postmarket Assurance: Medical Devices
April 21, 2016	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
February 4, 2014	OAI	Center for Devices and Radiological Health	Compliance: Devices
September 24, 2012	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
January 13, 2011	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices