FDA 483 - Plexus Electronica S. de R.L. de C.V. - November 29, 2018

Plexus Electronica S. de R.L. de C.V. in Zapopan, Jalisco, Mexico, was inspected by the FDA from November 26-29, 2018. The inspection revealed that the firm's procedures for receiving, reviewing, and evaluating complaints were not adequately established. Specifically, the firm failed to close medical device complaints in a timely manner, with several complaints remaining open for an average of 121 days.