BioXtek LLC – FDA Warning Letter, Feb 26, 2025

The FDA issued a Warning Letter to BioXtek LLC on December 1, 2025, following an inspection conducted from February 18-26, 2025. The letter addresses the company"s manufacture and marketing of human amniotic membrane-derived products, Sanoplast ECM and Sanoplast Duo. The primary violations concern the regulatory status of these products. The FDA determined that BioXtek"s products are unapproved new drugs, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act, and unlicensed biological products, violating section 351(a)(1) of the Public Health Service Act. The company markets these products for non-homologous uses, such as accelerating wound healing (including diabetic wounds and third-degree burns) and orthopedic applications like tendon repair and nerve regrowth. These stated uses mean the products are intended to perform functions beyond the basic barrier and protective role of amniotic membrane in the donor, thus failing to meet criteria for regulation solely as human cells, tissues, or cellular or tissue-based products (HCT/Ps) under 21 CFR Part 1271. Consequently, they require an approved Biologics License Application (BLA) before being introduced into interstate commerce. BioXtek LLC must respond within fifteen working days, detailing corrective actions taken or planned to address these violations and prevent recurrence. Failure to comply may lead to enforcement actions, including seizure or injunction. The FDA also advises a comprehensive review of all marketing materials for compliance.