What happened
Original notice title
Restorative Botanicals, LLC MARCS-CMS 674740, August 13, 2024
From the archived source record
Based on inspectional findings, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. We address your responses below, in relation to each of the noted violations. Adulterated Dietary Supplements The inspection of your facility on November 27 to December 12, 2023, 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 the My GUT Shrooms Gummies 60 ct. and My IMMUNE Shrooms Capsules 60 ct. dietary supplements manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because 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 limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3). Specifically, you failed to provide toxic element specifications for each of your mushroom components. Mushroom components, due to their common growing conditions, are at high risk for the accumulation of toxic elements. We note that although all of your component specifications included microbial limits, you failed to provide toxic element specifications for each of your mushroom components. You failed to, for each dietary supplement that you manufacture, establish product specifications for the identity of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
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
- fb2e75d9d0a9
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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