FDA 483 - The Metrix Company - April 25, 2019

The Metrix Company in Dubuque, IA, was cited for four significant issues related to its manufacturing of sterilized EVA dual chamber containers. The inspection revealed failures in submitting Medical Device Reports (MDRs), not reporting device corrections or removals to the FDA, and inadequacies in its corrective and preventive action (CAPA) procedures. Furthermore, the company failed to adequately document the results of its design risk analysis, particularly concerning manufacturing defects leading to sterile barrier failures.