Warning letter
ICU Medical: warning letter of Apr 4, 2025
FDA warning letter 702535 · Center for Devices and Radiological Health
Key facts
| Reference number | 702535 |
|---|---|
| Company | ICU Medical |
| Subject | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Issue date | Apr 4, 2025 |
| Posted date | Apr 22, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(i), 807.81(b), 880.5725 |
| Inspection city | Minneapolis |
| Inspection ZIP | 55442-1690 |
| Inspection start date | Jul 23, 2024 |
| 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: