FDA Inspection 820213 — TZ Medical, Inc.
The FDA completed an inspection of TZ Medical, Inc. on February 26, 2013 in Tualatin, OR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 26, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tualatin, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |