Warning letter
Synergy Health Concepts, Inc: warning letter of Sep 5, 2012
FDA warning letter 327419 · Center for Devices and Radiological Health
Key facts
| Reference number | 327419 |
|---|---|
| Company | Synergy Health Concepts, Inc |
| Subject | Sponsor/Monitor/Contract Research Organization |
| Issue date | Sep 5, 2012 |
| Posted date | Sep 5, 2012 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.140(d), 812.140(b), 812.2, 50, 50.27(a), 812.20, 812.40, 812.42, 812, 812.3(m), 812.140(a), 812.140(a)(2) and 2 more |
| Inspection city | Newport Beach |
| Inspection ZIP | 92660 |
| Inspection start date | Apr 10, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: