Warning letter
Empowered Diagnostics LLC: warning letter of Oct 6, 2022
FDA warning letter 638164 · Center for Devices and Radiological Health
Key facts
| Reference number | 638164 |
|---|---|
| Company | Empowered Diagnostics LLC |
| Subject | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| Issue date | Oct 6, 2022 |
| Posted date | Dec 27, 2022 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820.40, 820 |
| Inspection city | Pompano Beach |
| Inspection ZIP | 33069-4808 |
| Inspection start date | Feb 3, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: