Warning letter
Thermedx LLC: warning letter of Apr 8, 2015
FDA warning letter 448762 · Cincinnati District Office
Key facts
| Reference number | 448762 |
|---|---|
| Company | Thermedx LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Apr 8, 2015 |
| Posted date | Apr 21, 2015 |
| Issuing office | Cincinnati District Office |
| Product type | Devices |
| CFR sections cited | 820, 806, 806.10 |
| Inspection city | Solon |
| Inspection ZIP | 44139 |
| Inspection start date | Nov 19, 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: