FDA WARNING_LETTER - Restorative Botanicals, LLC - December 12, 2023

The FDA conducted an inspection of the facility at 1820 Industrial Circle, Unit B, Longmont, CO, from November 27 to December 12, 2023, identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). These violations render the My GUT Shrooms Gummies and My IMMUNE Shrooms Capsules adulterated under section 402(g)(1) of the Act. The firm received an FDA 483 and submitted multiple responses, which were deemed inadequate.

Key violations include the failure to establish adequate component specifications, with organoleptic tests being insufficient and toxic element specifications missing. The firm also failed to establish proper finished product specifications, with (b)(4) testing deemed inadequate for multi-component products and toxic element limits absent (21 CFR 111.70(e)). Quality control personnel failed to ensure manufacturing, packaging, and labeling operations aligned with Master Manufacturing Records (MMRs), specifically noting discrepancies between BPR components and product labels (21 CFR 111.105). Furthermore, the firm failed to prepare and follow written MMRs specific to each unique formulation and batch size (21 CFR 111.205(a)), and Batch Production Records (BPRs) lacked complete information, such as actual or representative labels (21 CFR 111.255(b)). The FDA requires a written response within 15 working days detailing corrective actions, recurrence prevention, and supporting documentation, warning that failure to comply may lead to legal action, including seizure and injunction.