Artegraft, Inc. – FDA Inspection, Jan 28, 2015

Record Details

This FDA Inspection record concerns Artegraft, Inc., with an inspection on January 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: Artegraft, Inc.
Inspection Date: January 28, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · acb41225-09ea-4d50-b723-0472b004f196

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 911848
FDA center: Medical Devices & Rad Health
Project area: Bioresearch Monitoring

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.250(b)Sampling plans
21 CFR 820.184DHR content

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Other FDA inspections of Artegraft, Inc.

Date	Classification	Office	Project area
June 25, 2026	Not classified	New Jersey District Office	Compliance: Devices
April 16, 2025	OAI	Center for Devices and Radiological Health	Compliance: Medical Devices
April 13, 2023	VAI	Center for Devices and Radiological Health	Compliance: Devices
February 16, 2018	NAI	Center for Devices and Radiological Health	Compliance: Devices
January 25, 2013	NAI	Center for Devices and Radiological Health	Compliance: Devices