# FDA 483 - Medtronic MiniMed, Inc. - July 22, 2016

Source: https://www.globalkeysolutions.net/records/483/medtronic-minimed-inc/b0db1635-54f6-453c-b9c1-627c7cfaed1a

> FDA 483 for Medtronic MiniMed, Inc. on July 22, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic MiniMed, Inc.
- Inspection Date: 2016-07-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Medtronic MiniMed Inc. in Northridge, CA, was inspected from July 5-22, 2016, revealing issues with device accountability. Specifically, records for the disposition of GST4C transmitters were not accurate or complete, leading to the use of incorrect software versions in a clinical study. This discrepancy was not identified until after clinical data was submitted to the FDA for IDE and PMA review.

## Related Documents

- [483 - 2016-07-22](https://www.globalkeysolutions.net/records/483/medtronic-minimed-inc/d8074749-ffe1-4cfc-9170-e4b042984627)
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- [EIR - 2023-03-10](https://www.globalkeysolutions.net/records/eir/medtronic-minimed-inc/f8c687cd-8b0e-4a31-9cc4-7e5e761196dd)

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

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

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