Warning letter
Lexion Medical LLC: warning letter of Jul 26, 2021
FDA warning letter 613588 · Center for Devices and Radiological Health
Key facts
| Reference number | 613588 |
|---|---|
| Company | Lexion Medical LLC |
| Subject | Adulterated and Misbranded Products, including Products Related to Coronavirus Disease 2019 (COVID-19) |
| Issue date | Jul 26, 2021 |
| Posted date | Aug 3, 2021 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 801.6 |
| Inspection city | Saint Paul |
| Inspection ZIP | 55103 |
| Inspection start date | Feb 17, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- NAI Linked inspection classification
- No 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: