Warning letter
Lusys Laboratories, Inc.: warning letter of Feb 17, 2022
FDA warning letter 625807 · Center for Devices and Radiological Health
Key facts
| Reference number | 625807 |
|---|---|
| Company | Lusys Laboratories, Inc. |
| Subject | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| Issue date | Feb 17, 2022 |
| Posted date | Mar 8, 2022 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| Inspection city | San Diego |
| Inspection ZIP | 92121 |
| Inspection start date | Sep 13, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 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: