FDA WARNING_LETTER - Eniva USA, Inc. - January 13, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Eniva USA, Inc., following an inspection of their Plymouth, MN facility from November 19, 2024, to January 13, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, specifically 21 CFR Part 111, which render their Immune Support (formerly Cold Buster) and Ashwagandha Gummies products adulterated.

The primary violations included the company"s failure to establish adequate product specifications for the identity, purity, strength, and composition of finished dietary supplement batches. The specifications for Immune Support and Ashwagandha Gummies were deemed insufficient to confirm these critical attributes. Additionally, Eniva failed to properly document material review and disposition decisions for "out of specification" results concerning incoming components and finished products. The FDA reviewed Eniva"s response to the initial inspection observations but found it inadequate, lacking evidence of corrective actions. The agency also raised concerns regarding the classification and formulation of certain "Vibe" products as acid foods, requesting further documentation. Eniva is required to submit a written response within 15 working days detailing specific corrective actions, preventative measures, and supporting evidence to address these serious issues.