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XO Biologix, LLC marketed and distributed MaviX™, an amniotic fluid-derived product, as an unapproved new drug and unlicensed biological product in violation of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. The company's product was also found to be adulterated due to significant violations of current good manufacturing practice (CGMP) requirements under 21 CFR parts 210 and 211, with manufacturing and quality control deficiencies identified at an unspecified contract manufacturer. Additionally, MaviX™ was determined to be misbranded under FD&C Act section 502(a). The FDA prohibited the company from introducing or delivering the product into interstate commerce.