FDA 483 - Natural Essentials Incorporated - March 10, 2023

Natural Essentials Incorporated, a manufacturer in Streetsboro, OH, was inspected and cited for significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate microbial contamination in raw materials, did not validate critical equipment, and did not adhere to its own quality control procedures for supplier evaluation and system sanitization. These issues indicate a high risk of producing adulterated OTC drug products.