FDA Inspection 621663 — Arthrex, Inc.
The FDA completed an inspection of Arthrex, Inc. on October 9, 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). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 9, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Naples, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2481 | 21 CFR 820.30(c) | Design input procedures - addressing conflicting requirement |
| 2598 | 21 CFR 820.30(d) | Design output procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 3838 | 21 CFR 820.40(a) | Document review procedures, designated individual |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |