Warning letter
Outset Medical, Inc.: warning letter of Jul 5, 2023
FDA warning letter 656485 · Center for Devices and Radiological Health
Key facts
| Reference number | 656485 |
|---|---|
| Company | Outset Medical, Inc. |
| Subject | Premarket Approval/Adulterated |
| Issue date | Jul 5, 2023 |
| Posted date | Jul 18, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 876.5665, 807.81(a)(3)(i), 807.81(b) |
| Inspection city | San Jose |
| Inspection ZIP | 95134 |
| Inspection start date | Jan 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: