FDA Inspection 1321408 — Depuy International Ltd.
The FDA completed an inspection of Depuy International Ltd. on May 29, 2026 in Leeds. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 29, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Leeds (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |