FDA Inspection
Abbott Diabetes Care, Inc.Abbott Diabetes Care, Inc. – FDA Inspection, Oct 23, 2025
Record Details
This FDA Inspection record concerns Abbott Diabetes Care, Inc., with an inspection on October 23, 2025, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- Abbott Diabetes Care, Inc.
- Inspection Date
- October 23, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 9e24f0b3-5726-43a4-84d7-e3556e753af6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1281240
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Abbott Diabetes Care, Inc.
15| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 21, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 29, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 19, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 4, 2017 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Abbott Diabetes Care, Inc.
- FDA Inspection 1226482 - 2023-11-16
- FDA Inspection 1168482 - 2022-04-21
- FDA Inspection 1141881 - 2021-04-29
- FDA Inspection 1062846 - 2018-07-19
- FDA Inspection 1033805 - 2017-12-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.