FDA WARNING_LETTER - Xo Biologix - January 05, 2024

The FDA inspected the facility at 609 Castle Ridge Rd, Suite 400, Austin, TX, from January 3-5, 2024. The company markets and distributes MaviX™, an amniotic fluid-derived product. The FDA determined MaviX™ is an unapproved new drug, an unlicensed biological product, adulterated, and misbranded.

MaviX™ is an unapproved new drug under section 505(a) of the FD&C Act and an unlicensed biological product under section 351(a)(1) of the PHS Act because it lacks an approved Biologics License Application (BLA). Promotional materials and the company website claim MaviX™ "Helps reduce pain, inflammation, and regenerate tissue," and is "Anti-Inflammatory" and "Anti-Fibrotic," indicating drug and biological product intent.

The product is adulterated due to significant Current Good Manufacturing Practice (CGMP) violations, as detailed in Warning Letter CBER 25-679023, violating section 501(a)(2)(B) of the FD&C Act and 21 CFR parts 210 and 211. The firm is responsible for CGMP compliance regardless of manufacturing location.

MaviX™ is misbranded under section 502(a) of the FD&C Act. The Instructions for Use (