FDA Inspection
Abbott Diabetes Care, Inc.Abbott Diabetes Care, Inc. – FDA Inspection, Oct 22, 2015
Record Details
This FDA Inspection record concerns Abbott Diabetes Care, Inc., with an inspection on October 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abbott Diabetes Care, Inc.
- Inspection Date
- October 22, 2015
- Product Type
- Devices
View Company Profile
ID · 12097a1c-72c3-4b63-9aa1-82ae25efd649
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 948198
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.198(a)Lack of or inadequate complaint 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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