FDA Inspection
Abbott Diabetes Care, Inc.Abbott Diabetes Care, Inc. – FDA Inspection, Mar 5, 2010
Record Details
This FDA Inspection record concerns Abbott Diabetes Care, Inc., with an inspection on March 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abbott Diabetes Care, Inc.
- Inspection Date
- March 5, 2010
- Product Type
- Devices
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ID · c113f5e4-dccd-4459-a814-4f82917ea4fc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 645900
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.20(b)(2)Resources
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)(2)Oral complaints
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.100(a)Lack of or inadequate procedures
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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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