FDA Inspection 633844 — Tornier, Inc
The FDA completed an inspection of Tornier, Inc on Dec 11, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 11, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bloomington, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |