FDA 483 - Nexagen, LLC - April 04, 2019

Nexgen, LLC, a dietary supplement manufacturer in Fayetteville, GA, was inspected by the FDA from March 26 to April 4, 2019. The inspection revealed numerous significant deficiencies in quality control operations, manufacturing records, and facility sanitation, with several issues being repeat observations. These violations indicate a systemic failure to adhere to good manufacturing practices, posing potential risks to product quality and consumer safety.