Artegraft, Inc. – FDA Inspection, Apr 16, 2025

Record Details

This FDA Inspection record concerns Artegraft, Inc., with an inspection on April 16, 2025, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.

Company: Artegraft, Inc.
Inspection Date: April 16, 2025
Product Type: Medical Devices & Rad Health
Office: Center for Devices and Radiological Health
People: Frank J. Marciniak (Issuing Officer)
Matthew W. Kyle (Company Rep)
Monica L. Gutierrez (Issuing Officer)

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ID · 4ba57aee-568b-4a33-a2e7-c5fb71467292

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1235542
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 820.184DHR - 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 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule

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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 13, 2023	VAI	Center for Devices and Radiological Health	Compliance: Devices
February 16, 2018	NAI	Center for Devices and Radiological Health	Compliance: Devices
January 28, 2015	VAI	Center for Devices and Radiological Health	Bioresearch Monitoring
January 25, 2013	NAI	Center for Devices and Radiological Health	Compliance: Devices