FDA 483 - Salud Natural Entrepreneur, Inc. - May 21, 2021

An FDA inspection of Salud Natural Entrepreneur, Inc., a dietary supplement manufacturer in Waukegan, IL, revealed numerous significant deficiencies in their manufacturing practices. The firm failed to establish and follow specifications for components and finished products, conduct identity testing, maintain adequate quality control, and ensure proper sanitation and environmental controls. Many of these violations, including issues with master and batch production records, were repeat observations from previous inspections.