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Eniva USA, Inc. received a warning for manufacturing adulterated dietary supplements (Immune Support and Ashwagandha Gummies) in violation of Current Good Manufacturing Practice regulations. The FDA identified critical CGMP failures during a November 2024 to January 2025 inspection, including the company's failure to establish proper product specifications for identity, purity, strength, and composition of finished batches, with the company maintaining only blank specification documents rather than complete specifications. The violations were significant enough to render the finished dietary supplements adulterated under federal law, and the company's February 2025 response to the inspection observations was found to be inadequate.