Warning letter
Cue Health, Inc.: warning letter of May 9, 2024
FDA warning letter 675673 · Center for Devices and Radiological Health
Key facts
| Reference number | 675673 |
|---|---|
| Company | Cue Health, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 9, 2024 |
| Posted date | May 13, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(i), 807.81(b) |
| Inspection city | San Diego |
| Inspection ZIP | 92121 |
| Inspection start date | Oct 17, 2023 |
| Letter on fda.gov | fda.gov |
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: