FDA 483 - Dynex Technologies, Inc. - February 18, 2022

Dynex Technologies, Inc. in Chantilly, VA, was inspected by the FDA from February 7-18, 2022, and received a Form FDA-483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding corrective and preventive actions, supplier controls, and customer complaint handling processes. These issues indicate a lack of adherence to established procedures and regulatory requirements.