FDA Inspection
Abbott Diabetes Care, Inc.Abbott Diabetes Care, Inc. – FDA Inspection, Mar 13, 2009
Record Details
This FDA Inspection record concerns Abbott Diabetes Care, Inc., with an inspection on March 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abbott Diabetes Care, Inc.
- Inspection Date
- March 13, 2009
- Product Type
- Devices
View Company Profile
ID · 51aa6e00-7e02-4edf-bdb8-997daf9613d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 570573
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.25(b)Training
- 21 CFR 820.25(b)Training - 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 |
|---|---|---|---|
| October 23, 2025 | OAI | San Francisco District Office | Compliance: Medical Devices |
| 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 |
Other documents for Abbott Diabetes Care, Inc.
- FDA Inspection 1281240 - 2025-10-23
- FDA Inspection 1226482 - 2023-11-16
- FDA Inspection 1168482 - 2022-04-21
- FDA Inspection 1141881 - 2021-04-29
- FDA Inspection 1062846 - 2018-07-19
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