Warning letter
Signal Medical Corporation: warning letter of Dec 15, 2014
FDA warning letter 439241 · Detroit District Office
Key facts
| Reference number | 439241 |
|---|---|
| Company | Signal Medical Corporation |
| Subject | Premarket Approval/Adulterated |
| Issue date | Dec 15, 2014 |
| Posted date | May 26, 2015 |
| Issuing office | Detroit District Office |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(i), 807.81(b) |
| Inspection city | Marysville |
| Inspection ZIP | 48040 |
| Inspection start date | Jul 31, 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: