Warning letter
SyncThink, Inc.: warning letter of Jul 31, 2017
FDA warning letter 498523 · Center for Devices and Radiological Health
Key facts
| Reference number | 498523 |
|---|---|
| Company | SyncThink, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Jul 31, 2017 |
| Posted date | Sep 5, 2017 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(ii), 807.81(b) |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
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: