FDA 483 - Elemental Herbs, Inc. - December 20, 2024

Elemental Herbs, Inc. in Morro Bay, CA, a private label distributor of OTC drug products, was cited for significant deficiencies during an FDA inspection. The firm failed to establish an adequate quality control unit, neglected to investigate drug complaints, and lacked proper employee training in current good manufacturing practices. These issues indicate a severe lack of oversight in the manufacturing and quality assurance of their drug products.