FDA 483 - NAC Marketplace Company, LLC - August 05, 2016

NAC Marketing dba New Vitality in Edgewood, NY, was cited for significant failures in its quality control and complaint handling systems. The inspection revealed a lack of investigation into numerous serious adverse event complaints, including multiple stroke reports linked to its Super Beta Prostate dietary supplement. Additionally, the firm failed to establish essential written procedures for labeling, returned products, quality control material review, and reserve sample retention.