# FDA 483 - Medtronic MiniMed, Inc. - March 14, 2018

Source: https://www.keypedia.com/records/483/medtronic-minimed-inc/bd3416e8-e121-4749-ac24-0cd1c7239a43

> FDA 483 for Medtronic MiniMed, Inc. on March 14, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic MiniMed, Inc.
- Inspection Date: 2018-03-14
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Medtronic Inc. in Northridge, CA, was cited for significant deficiencies in its medical device reporting and complaint handling processes. The firm failed to submit thousands of Medical Device Reports within the required 30-day timeframe and did not adequately review, evaluate, or investigate complaints involving potential device failures that led to adverse events or serious injuries. These issues indicate a systemic problem with post-market surveillance and quality system compliance.

## Related Documents

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- [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/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

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