FDA Inspection
Medtronic MiniMed, Inc.Medtronic MiniMed, Inc. – FDA Inspection, Mar 10, 2023
Record Details
This FDA Inspection record concerns Medtronic MiniMed, Inc., with an inspection on March 10, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8d4837ff-b122-4e9b-96ed-06ae9c86bb88
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1199488
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Medtronic MiniMed, Inc.
13| Date | Classification | Office | Project area |
|---|---|---|---|
| January 3, 2024 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 7, 2021 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 15, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 14, 2018 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| August 14, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medtronic MiniMed, Inc.
- FDA Inspection 1226943 - 2024-01-03
- FDA Inspection 1145642 - 2021-07-07
- FDA Inspection 1082648 - 2019-02-15
- FDA Inspection 1044249 - 2018-03-14
- FDA Inspection 1022946 - 2017-08-14
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