# FDA 483 - Medtronic MiniMed, Inc. - July 07, 2021

Source: https://www.keypedia.com/records/483/medtronic-minimed-inc/dc5fcb93-52a2-45c9-b80b-62c194974da0

> FDA 483 for Medtronic MiniMed, Inc. on July 07, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medtronic MiniMed, Inc.
- Inspection Date: 2021-07-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Medtronic MiniMed in Northridge, CA, was cited for significant deficiencies in its quality system, particularly concerning corrective and preventive actions (CAPA), complaint handling, and Medical Device Reporting (MDR). The inspection revealed failures to adequately assess and mitigate risks associated with insulin pump retainer rings and cybersecurity vulnerabilities, leading to delayed and ineffective recalls, and a failure to thoroughly investigate device malfunctions and submit timely MDRs for serious adverse events, including deaths and serious injuries.

## Related Documents

- [483 - 2016-07-22](https://www.keypedia.com/records/483/medtronic-minimed-inc/d8074749-ffe1-4cfc-9170-e4b042984627)
- [483 - 2016-07-22](https://www.keypedia.com/records/483/medtronic-minimed-inc/b0db1635-54f6-453c-b9c1-627c7cfaed1a)
- [483 - 2018-03-14](https://www.keypedia.com/records/483/medtronic-minimed-inc/bd3416e8-e121-4749-ac24-0cd1c7239a43)
- [EIR - 2019-02-15](https://www.keypedia.com/records/eir/medtronic-minimed-inc/1d750d30-1485-45d4-b6ff-6e19fff6114a)
- [EIR - 2023-03-10](https://www.keypedia.com/records/eir/medtronic-minimed-inc/f8c687cd-8b0e-4a31-9cc4-7e5e761196dd)

## Related Officers

- [Investigator](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/medtronic-minimed-inc/a75f6a75-6d10-41f1-8c92-839535f005bf

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6