Eniva USA, Inc.
FDA issued a warning letter to Eniva USA, Inc. (Plymouth, MN) following a November 2024–January 2025 facility inspection, citing serious CGMP violations under 21 CFR Part 111 for its Immune Support (formerly Cold Buster) and Ashwagandha Gummies dietary supplements. The violations include failure to establish adequate finished product specifications for identity, purity, strength, and composition, and failure to document material review and disposition decisions. FDA found the company's February 2025 corrective-action responses inadequate and lacking supporting evidence. The letter warns that failure to address these violations may result in seizure or injunction.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker