FDA 483 - Accord Media, LLC - May 13, 2019

An FDA inspection of Accred Media, LLC in New York, NY, an initial importer of the Truth Vitality Lux Renew device, revealed significant quality system deficiencies. The firm failed to establish procedures for finished device acceptance, document supplier evaluations, ensure devices carried control numbers through distribution, and maintain a device master record. These observations indicate a lack of adequate controls over device quality and manufacturing processes.