Company
United StatesArtegraft, Inc., North Brunswick, NJ – FDA Inspections
Inspection records and compliance data for Artegraft, Inc. in North Brunswick, New Jersey. 8 FDA inspections on record (2 OAI), 3 Form 483s, last inspected June 25, 2026.
Company Profile
This profile covers Artegraft, Inc. based in North Brunswick, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 2
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected March 8, 2010. Last inspected June 25, 2026.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Lack of or inadequate process validation3 inspections
- Lack/Inad procedure-Monitoring/Control of Validated Proces2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 25, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1325342 |
| April 16, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1235542 |
| April 13, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1202728 |
| February 16, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1044392 |
| January 28, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 911848 |
| January 25, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 816080 |
| December 20, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 704445 |
| March 8, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 650674 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Artegraft, Inc.
FEI Number
1000121696
Address
206 N Center Dr, North Brunswick, New Jersey 08902, United States
Country
United States
ID: ea31640f-5897-4972-8d68-16ea7ca1d8eb