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

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.