Warning letter
Brava, LLC: warning letter of Aug 28, 2014
FDA warning letter 432371 · Center for Devices and Radiological Health
Key facts
| Reference number | 432371 |
|---|---|
| Company | Brava, LLC |
| Subject | Sponsor/Monitor/Contract Research Organization |
| Issue date | Aug 28, 2014 |
| Posted date | Dec 16, 2015 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 54.1(b), 812.40, 812, 812.46(a), 812.150(b)(2), 812.150(b)(10), 812.150(b)(8) |
| Inspection city | Miami |
| Inspection ZIP | 33186 |
| Inspection start date | Feb 4, 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: