FDA 483 - Mytrex, Inc. - July 19, 2022

Mytrex, Inc., a manufacturer of personal emergency response systems in South Jordan, UT, was cited for eight significant quality system deficiencies during an FDA inspection. The observations highlight systemic failures in process validation, device history record maintenance, control of nonconforming product, complaint handling, CAPA effectiveness verification, equipment calibration, and supplier management. These issues indicate a broad lack of adherence to established procedures and regulatory requirements for medical device manufacturing.