FDA 483 - Calapro Inc Dba Calatex Inc - August 21, 2019

Calapro Inc Dba Calatex Inc, an importer in Santa Ana, CA, was inspected by the FDA from August 20-21, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the lack of established procedures for complaint handling, Medical Device Reporting (MDR), and corrective and preventive actions. These findings indicate a fundamental absence of critical operational controls.