FDA 483 - Med-Tex, LLC dba Med Textile - July 18, 2019

An FDA inspection of Med-Tex, LLC dba Med Textile in Midlothian, VA, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for corrective and preventive actions (a repeat observation), purchasing controls, and the control of non-conforming products. These findings indicate a lack of fundamental quality management system documentation and implementation.