# FDA 483 - Minnesota MedTec, Inc. - August 15, 2025

Source: https://www.globalkeysolutions.net/records/483/minnesota-medtec-inc/d04af3d6-c416-497b-acd7-ad9dfbafc46c

> FDA 483 for Minnesota MedTec, Inc. on August 15, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Minnesota MedTec, Inc.
- Inspection Date: 2025-08-15
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Minnesota Medtec, Inc., a contract manufacturer in Maple Grove, MN, received a Form FDA-483 citing two observations related to its quality system. The inspection revealed deficiencies in establishing adequate procedures for personnel training and ensuring that all purchased products and services conform to specified requirements. Specifically, the firm failed to train key personnel according to its SOPs and did not properly approve critical suppliers.

## Related Documents

- [483 - 2019-12-11](https://www.globalkeysolutions.net/records/483/minnesota-medtec-inc/0f68ad02-4a13-4d57-87a3-367cba747b7d)

## Related Officers

- [Alicia U. Jacobo](https://www.globalkeysolutions.net/people/alicia-u-jacobo/5f75a995-c0df-4615-be88-d401df48ad26)

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

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