FDA Inspection 772653 — Depuy International Ltd.
The FDA completed an inspection of Depuy International Ltd. on February 16, 2012 in Leeds. 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
- February 16, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Leeds (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 778 | 21 CFR 803.52(f)(1) | Type of Reportable Event |