Warning letter
Abbott Diabetes Care, Inc.: warning letter of Jan 23, 2026
FDA warning letter 722046 · Center for Devices and Radiological Health
Key facts
| Reference number | 722046 |
|---|---|
| Company | Abbott Diabetes Care, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jan 23, 2026 |
| Posted date | Feb 3, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 862.1355(b)(3), 862.1355, 862.1355(b)(1)(ii), 820 |
| Inspection city | Alameda |
| Inspection ZIP | 94502 |
| Inspection start date | Oct 14, 2025 |
| 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: