Restorative Botanicals, LLC
FDA issued a warning letter to Restorative Botanicals, LLC (Longmont, CO) following a November–December 2023 facility inspection that found significant Current Good Manufacturing Practice (CGMP) violations in the production of two dietary supplement products: My GUT Shrooms Gummies 60 ct. and My IMMUNE Shrooms Capsules 60 ct. The violations included failure to establish adequate component identity and contamination-limit specifications (including toxic element testing for mushroom ingredients), discrepancies between batch production records and product labels, and incomplete master manufacturing and batch production records. FDA declared the products adulterated under 21 U.S.C. § 342(g)(1) and warned that failure to correct 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. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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