# FDA 483 - Minnesota MedTec, Inc. - December 11, 2019

Source: https://www.keypedia.com/records/483/minnesota-medtec-inc/0f68ad02-4a13-4d57-87a3-367cba747b7d

> FDA 483 for Minnesota MedTec, Inc. on December 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Minnesota MedTec, Inc.
- Inspection Date: 2019-12-11
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Minnesota MedTec, Inc., a medical device contract manufacturer in Maple Grove, MN, revealed significant deficiencies in their quality system. Observations included inadequate training procedures for production operators, a failure to adequately establish corrective and preventive actions, and a lack of proper procedures for receiving and evaluating customer complaints. These issues indicate systemic problems in maintaining product quality and compliance.

## Related Documents

- [483 - 2025-08-15](https://www.keypedia.com/records/483/minnesota-medtec-inc/d04af3d6-c416-497b-acd7-ad9dfbafc46c)

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)
- [Benjamin W. Anderson](https://www.keypedia.com/people/benjamin-w-anderson/a3c0961c-6a83-4bd7-abb8-02c5c8dd3a35)

Company: https://www.keypedia.com/companies/minnesota-medtec-inc/b6b86664-630b-43ed-b06a-4ec4b3dfe8b9

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d