What happened
Original notice title
Eniva USA, Inc. MARCS-CMS 706565, September 10, 2025
From the archived source record
Based on inspectional findings and review of product labels collected during the inspections, as well as review of your website, www.eniva.com, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Adulterated Dietary Supplements The inspection of your facility from November 19, 2024, through January 13, 2025, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your Immune Support (previously called Cold Buster) and Ashwagandha Gummies dietary supplements to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Your significant violations of the CGMP requirements are as follows: 1) You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplements, as required by 21 CFR 111.70(e). We have reviewed your response to the FDA Form 483, received February 5, 2025, and find it does not adequately address the violation. We have reviewed your response to the FDA Form 483, received February 5, 2025, and find it does not adequately address the violation. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- dc681450a361
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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