FDA Inspection 601510 — Smith & Nephew, Inc. Advanced Surgical Devices Division
The FDA completed an inspection of Smith & Nephew, Inc. Advanced Surgical Devices Division on July 31, 2009 in Oklahoma City, OK. 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
- July 31, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oklahoma City, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 4189 | 21 CFR 820.198(a) | General |