Warning letter
TZ Medical Inc.: warning letter of Apr 10, 2012
FDA warning letter 240514 · Seattle District Office
Key facts
| Reference number | 240514 |
|---|---|
| Company | TZ Medical Inc. |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Apr 10, 2012 |
| Posted date | Apr 10, 2012 |
| Issuing office | Seattle District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17(a), 807.81(a)(3)(ii), 803.50(a), 807.81(b) |
| Inspection city | Tualatin |
| Inspection ZIP | 97062 |
| Inspection start date | Aug 11, 2011 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: