FDA 483 - Ecotec Manufacturing, Inc. - February 05, 2026

An FDA inspection of Ecotec Manufacturing, Inc. in Okeechobee, FL, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate documentation for corrective and preventive actions (CAPA), specifically lacking root cause analysis procedures. Additionally, the firm failed to adequately maintain complaint handling records and records of reworked medical devices.