# FDA 483 - Medtronic MiniMed, Inc. - March 10, 2023

Source: https://www.keypedia.com/records/483/medtronic-minimed-inc/0d88e323-7115-44c8-aec9-95d748e3bc5c

> FDA 483 for Medtronic MiniMed, Inc. on March 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic MiniMed, Inc.
- Inspection Date: 2023-03-10
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Medtronic MiniMed, Inc. in Northridge, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for complaint handling, corrective and preventive actions, and environmental controls in their cleanroom. These issues indicate a moderate to severe level of non-compliance impacting medical device manufacturing.

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## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)
- [investigator](https://www.keypedia.com/people/elizabeth-a-dakan/f701338d-0484-431b-8bd5-9db442b5f079)
- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

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