XO Biologix, LLC
FDA issued a warning letter to XO Biologix, LLC (Austin, TX) on December 12, 2024, regarding its amniotic fluid-derived product MaviX™. The agency found MaviX™ to be an unapproved new drug and unlicensed biological product under the FD&C Act and PHS Act, marketed with claims that it reduces pain, inflammation, and regenerates tissue without an approved Biologics License Application. The product was also found adulterated due to CGMP violations at its manufacturer and misbranded due to false or misleading labeling, including inconsistent and unsupported shelf-life claims. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure and/or injunction.
Flagged claims (5)
MaviX™ is a heterogeneous, complex mixture of cell and tissue building blocks, which play a key role in repair and regeneration
the tissue is processed and may be cut into predetermined size patches using sterile cutting tools
Helps reduce pain, inflammation, and regenerate tissue
Anti-Fibrotic
Anti-Inflammatory
Required actions (2)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in regulatory action without further notice. Such actions may include seizure and/or injunction.
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