Warning letter
Solta Medical, Inc.: warning letter of Nov 28, 2012
FDA warning letter 365578 · Center for Devices and Radiological Health
Key facts
| Reference number | 365578 |
|---|---|
| Company | Solta Medical, Inc. |
| Subject | Sponsor/Monitor/Contract Research Organization |
| Issue date | Nov 28, 2012 |
| Posted date | Nov 28, 2012 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812, 812.43(c), 54, 50.25(b)(1), 812.40, 812.140(b)(2) |
| Inspection city | Pleasanton |
| Inspection ZIP | 94566 |
| Inspection start date | Jul 12, 2012 |
| 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: