Warning letter
CoRE Labs, LLC: warning letter of Feb 20, 2013
FDA warning letter 343219 · Denver District Office
Key facts
| Reference number | 343219 |
|---|---|
| Company | CoRE Labs, LLC |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Feb 20, 2013 |
| Posted date | Feb 20, 2013 |
| Issuing office | Denver District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 820, 820.40, 803.50(b), 1002.12, 1002.30(a)(2), 1010.2(a), 1002.1, 1020.30(n) |
| Inspection city | Englewood |
| Inspection ZIP | 80110 |
| Inspection start date | Jul 16, 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: