LXR Biotech, LLC
FDA issued a warning letter to LXR Biotech, LLC (Rochester Hills, MI) following a February–March 2025 facility inspection, citing serious Current Good Manufacturing Practice (CGMP) violations related to their dietary supplement products Eternal Energy Grape and Eternal Energy Tropical Punch. The violations include failure to establish complete finished product specifications, failure to establish identity specifications for components, and use of testing methods that are not scientifically valid to confirm ingredient identity. FDA found the products adulterated under 21 U.S.C. 342(g)(1) and warned that failure to correct these 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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