Company
United StatesAbbott Diabetes Care, Inc., Alameda, CA – FDA Inspections
Inspection records and compliance data for Abbott Diabetes Care, Inc. in Alameda, California. 16 FDA inspections on record (3 OAI), 2 Form 483s, 2 warning letters, last inspected October 23, 2025.
Company Profile
This profile covers Abbott Diabetes Care, Inc. based in Alameda, California, United States.
FDA Inspection History
- FDA inspections
- 16
- OAI
- 3
- VAI
- 6
- NAI
- 5
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 2
First inspected March 13, 2009. Last inspected October 23, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures3 inspections
- Individual Report of Malfunction2 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (16)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 23, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1281240 |
| November 16, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1226482 |
| April 21, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1168482 |
| April 29, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1141881 |
| July 19, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1062846 |
| December 4, 2017 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1033805 |
| October 13, 2017 | Not classified | Medical Devices & Rad Health | 1050546 |
| October 21, 2016 | Not classified | Medical Devices & Rad Health | 996333 |
| March 10, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 967465 |
| October 22, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 948198 |
| February 7, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 867215 |
| May 31, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 835725 |
| July 24, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 791938 |
| March 5, 2010 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 645900 |
| March 13, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 586562 |
| March 13, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 570573 |
FDA documents
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Abbott Diabetes Care, Inc.
FEI Number
3002803444
Address
1360 S Loop Rd, Alameda, California 94502, United States
Country
United States
ID: bde5d1eb-44f0-4a7d-847b-6274f46dcbb7