FDA Inspection
Arthrosurface, Inc.Arthrosurface, Inc. – FDA Inspection, Apr 1, 2026
Record Details
This FDA Inspection record concerns Arthrosurface, Inc., with an inspection on April 1, 2026, issued by the New England District Office, covering medical devices & rad health.
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ID · eeb59ec8-3e04-4307-94cb-6487c401ca98
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1311064
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
1- ISO 13485:2016 Clause 7.5.7Sterilization and sterile barrier system validation procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Arthrosurface, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2025 | Not classified | New England District Office | |
| November 2, 2018 | Not classified | New England District Office | |
| December 8, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 5, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 9, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arthrosurface, Inc.
- FDA Inspection 1279142 - 2025-08-06
- FDA Inspection 1108600 - 2018-11-02
- FDA Inspection 954082 - 2015-12-08
- FDA Inspection 947456 - 2015-10-05
- FDA Inspection 806730 - 2012-11-09
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