FDA 483 - NutraCap Holdings LLC - December 06, 2021

NutraCap Holdings LLC dba NutraCap Labs LLC in Norcross, GA, a dietary supplement manufacturer, was inspected by the FDA from November 1 to December 6, 2021. The inspection revealed nine significant observations related to inadequate quality control, lack of established product and component specifications, insufficient supplier qualification, mislabeling, and failure to identify and control allergens. Several issues were repeat observations from a previous Warning Letter, indicating persistent non-compliance with manufacturing regulations.