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Talk to a SpecialistTalk to a SpecialistBioXtek LLC manufactured and distributed Sanoplast ECM and Sanoplast Duo, human amniotic membrane-derived biologics, without required FDA approval or licensure in violation of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. An FDA inspection conducted in February 2025 documented that the company was marketing these products for therapeutic applications including disease treatment and prevention, and promoting them via their website, despite lacking either an approved New Drug Application (NDA) or Biologics License Application (BLA). The company was prohibited from introducing or delivering these unapproved biological products into interstate commerce.