LXR Biotech, LLC – FDA Warning Letter, Mar 12, 2025

The FDA issued a Warning Letter to LXR Biotech, LLC following an inspection conducted from February 25 to March 12, 2025. The inspection revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), leading to the classification of their products, Eternal Energy Grape and Eternal Energy Tropical Punch, as adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations included the company's failure to establish comprehensive product specifications for the identity, purity, strength, and composition of finished dietary supplement batches, specifically noting omitted ingredients. LXR Biotech also failed to establish adequate identity specifications for individual components, such as caffeine anhydrous and taurine, as their existing analytical methods lacked sufficient specificity for unique identification. Furthermore, the firm did not ensure that the tests and examinations used to verify product specifications were scientifically valid, particularly regarding third-party identity testing for caffeine anhydrous where the validity of the reference standard was questionable.

The FDA requires LXR Biotech to respond in writing within 15 working days, detailing the specific corrective actions taken, measures to prevent recurrence, and supporting documentation. Failure to adequately address these violations may result in further legal action, including product seizure or injunction.