FDA Inspection 1311064 — Arthrosurface, Inc.
The FDA completed an inspection of Arthrosurface, Inc. on April 1, 2026 in West Bridgewater, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 1, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Bridgewater, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23175 | ISO 13485:2016 Clause 7.5.7 | Sterilization and sterile barrier system validation procedures not documented |