Company
United StatesArthrosurface, Inc., Franklin, MA – FDA Inspections
Inspection records and compliance data for Arthrosurface, Inc. in Franklin, Massachusetts. 7 FDA inspections on record, 2 Form 483s, last inspected April 01, 2026.
Company Profile
This profile covers Arthrosurface, Inc. based in Franklin, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 11, 2010. Last inspected April 1, 2026.
Most cited issue areas
- Design verification - Lack of or inadequate procedures1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 1, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1311064 |
| August 6, 2025 | Not classified | Biologics | 1279142 |
| November 2, 2018 | Not classified | Medical Devices & Rad Health | 1108600 |
| December 8, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 954082 |
| October 5, 2015 | NAI | Biologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies | 947456 |
| November 9, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 806730 |
| June 11, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 671376 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Arthrosurface, Inc.
FEI Number
3004154314
Address
28 Forge Pkwy, Franklin, Massachusetts 02038, United States
Country
United States
ID: 4d18e49d-3a81-498f-a2cf-63d66c4907f5