FDA WARNING_LETTER - NexCell Scientific Inc - February 05, 2026

NexCell Scientific Inc., located in Irvine, California, received an FDA warning letter following inspections conducted between December 2025 and February 2026. The FDA determined that the company’s umbilical cord blood-derived total nucleated cell product is being marketed as an unapproved new drug and an unlicensed biological product. These products are promoted for treating various conditions, such as inflammation and neurological disorders, which do not qualify as basic donor functions. Consequently, the products fall under the regulatory framework of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, requiring a Biologics License Application (BLA) that the company currently lacks. The inspection also identified significant violations of Current Good Manufacturing Practice (CGMP). Key issues include a lack of process validation, inadequate aseptic procedures to prevent contamination, and a failure to investigate previous sterility test failures. The FDA also noted the absence of an independent quality control unit and insufficient environmental monitoring. Because NexCell"s initial response lacked documentation and failed to address the risks to existing inventory, the FDA requires a new written response within 15 working days. This response must include a detailed corrective action plan and evidence of compliance to avoid potential legal actions, such as product seizure or injunctions.