FDA Inspection
Medtronic MiniMed, Inc.Medtronic MiniMed, Inc. – FDA Inspection, Jul 7, 2021
Record Details
This FDA Inspection record concerns Medtronic MiniMed, Inc., with an inspection on July 7, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic MiniMed, Inc.
- Inspection Date
- July 7, 2021
- Product Type
- Devices
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ID · d6b25b74-2795-4765-834a-59933f9912cb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1145642
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR 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 |
| March 10, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1199488 - 2023-03-10
- FDA Inspection 1082648 - 2019-02-15
- FDA Inspection 1044249 - 2018-03-14
- FDA Inspection 1022946 - 2017-08-14
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