FDA 483 - Invotec International Inc. - February 05, 2019

Invotec International Inc. in Jacksonville, FL, a medical device manufacturer, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed deficiencies in process validation, monitoring of process parameters, corrective and preventive actions, purchasing controls, and device history record maintenance. These issues indicate a lack of adequate quality system procedures for manufacturing and controlling medical devices.