FDA Inspection 586544 — Tornier, Inc
The FDA completed an inspection of Tornier, Inc on May 14, 2009 in Bloomington, MN. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 14, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bloomington, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |