# FDA 483 - Nortech Systems, Inc. - April 14, 2023

Source: https://www.keypedia.com/records/483/nortech-systems-inc/f1ac3acd-b23e-42ee-aebc-9991d336827f

> FDA 483 for Nortech Systems, Inc. on April 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nortech Systems, Inc.
- Inspection Date: 2023-04-14
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Nortech Systems, Inc. in Milaca, MN, was inspected by the FDA from April 12-14, 2023. The inspection revealed one observation regarding the inadequate establishment and implementation of corrective and preventive action (CAPA) procedures. Specifically, the firm failed to document a design change made to probe models in response to customer complaints within its CAPA system.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.keypedia.com/companies/nortech-systems-inc/34e34efe-16a1-4d22-97cf-fd064220737f

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