FDA 483 - Ecotec Manufacturing, Inc. - June 26, 2019

Ecotec Manufacturing, Inc. in Okeechobee, FL, a medical device manufacturer, was inspected by the FDA from June 24-26, 2019. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning design controls, process validation, purchasing controls, and complaint handling. These issues indicate a pervasive lack of established procedures and documentation for critical aspects of medical device manufacturing.