FDA Inspection 624886 — Arthrex, Inc.
The FDA completed an inspection of Arthrex, Inc. on October 30, 2009 in Naples, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 30, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Naples, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3681 | 21 CFR 820.70(b) | Verification or validation of changes |