Warning letter
Rodo Medical, Inc.: warning letter of Feb 20, 2015
FDA warning letter 441076 · Center for Devices and Radiological Health
Key facts
| Reference number | 441076 |
|---|---|
| Company | Rodo Medical, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Feb 20, 2015 |
| Posted date | Mar 9, 2015 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.2(b)(1)(iv), 812.40, 812.42, 812.46, 812, 812.3(m)(4), 812.2(b)(1)(v), 812.20(a), 812.20(a)(1) |
| Inspection city | San Jose |
| Inspection ZIP | 95134 |
| Inspection start date | Jul 29, 2014 |
| 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: