Warning letter
Insightra Medical Inc: warning letter of May 21, 2015
FDA warning letter 455892 · Los Angeles District Office
Key facts
| Reference number | 455892 |
|---|---|
| Company | Insightra Medical Inc |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 21, 2015 |
| Posted date | Jun 2, 2015 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a), 820, 803, 803.3, 803.17 |
| Inspection city | Clarksville |
| Inspection ZIP | 37043 |
| Inspection start date | Feb 19, 2015 |
| 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: