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Talk to a SpecialistTalk to a SpecialistRestorative Botanicals, LLC received a warning for manufacturing adulterated dietary supplements (My GUT Shrooms Gummies and My IMMUNE Shrooms Capsules) in violation of Current Good Manufacturing Practice (CGMP) regulations under 21 CFR Part 111. The facility failed to establish required component specifications, including identity specifications for ingredients used in manufacturing dietary supplements. The violations were identified during an FDA inspection conducted from November 27 through December 12, 2023, at the company's Longmont, Colorado facility, with the FDA providing an inspectional observations form and reviewing multiple written responses from the company between January and June 2024.