FDA Inspection
Medtronic MiniMed, Inc.Medtronic MiniMed, Inc. – FDA Inspection, Mar 14, 2018
Record Details
This FDA Inspection record concerns Medtronic MiniMed, Inc., with an inspection on March 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · edacd75d-2a95-421f-9b12-b7a586c0639f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044249
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
Full citation text and observation details available on the Dashboard.
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 |
| March 10, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 |
| 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 1199488 - 2023-03-10
- FDA Inspection 1145642 - 2021-07-07
- FDA Inspection 1082648 - 2019-02-15
- FDA Inspection 1022946 - 2017-08-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.