FDA 483 - Ecotec Manufacturing, Inc. - April 20, 2023

Ecotec Manufacturing, Inc. in Okeechobee, FL, was inspected by the FDA from April 18-20, 2023. The inspection revealed two significant issues related to the firm's quality system, specifically concerning inadequate document control and a lack of established procedures for management review. These observations indicate deficiencies in the firm's operational and quality management processes.