Angiodynamics, Inc. – FDA Inspection, Dec 16, 2009

Record Details

This FDA Inspection record concerns Angiodynamics, Inc., with an inspection on December 16, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Angiodynamics, Inc.
Inspection Date: December 16, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · eb07b4c2-4893-446b-a78d-01ead9545348

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 636113
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.72(a)Equipment suitability & capability
21 CFR 820.198(a)General
21 CFR 820.198(a)(1)Uniform and timely processing
21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
21 CFR 820.30(d)Design output procedures
21 CFR 820.160(a)Control/distribution procedures
21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate

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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
February 10, 2012	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices