FDA Inspection 954082 — Arthrosurface, Inc.
The FDA completed an inspection of Arthrosurface, Inc. on December 8, 2015 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
- December 8, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- West Bridgewater, MA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2994 | 21 CFR 812.140(b)(3) | Sponsor records of investigator agreements inadequate |