FDA Inspection 596100 — Biomet UK Ltd.
The FDA completed an inspection of Biomet UK Ltd. on July 2, 2009 in Bridgend. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Bridgend (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |