FDA WARNING_LETTER - Platinum Biologics LLC - August 26, 2025

The FDA issued a warning letter to Platinum Biologics, LLC, located at 1510 E Colonial Drive, Suite 103, Orlando, FL, on August 15, 2025. The letter addresses violations related to the company"s sale of umbilical cord-derived products, specifically Nano PRP Jelly, Nano Flex, NanoEx, and Nano Xsomes, which are marketed for allogeneic use. These products are deemed unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and unlicensed biological products under section 351(a)(1) of the Public Health Service Act (PHS Act).

The FDA"s review found that these products are intended for the diagnosis, cure, mitigation, treatment, or prevention of diseases, thus classifying them as drugs and biological products. Additionally, the Nano PRP Jelly and Nano Flex products do not meet regulatory criteria for minimal manipulation and homologous use under 21 CFR part 1271, as their processing alters the original characteristics of the umbilical cord tissue.

The FDA requires Platinum Biologics to cease the interstate commerce of these products unless they obtain the necessary Biologics License Application (BLA) approvals. The company must respond within 15 working days, detailing corrective actions or providing justification if they believe their products are compliant. Failure to address these issues may result in enforcement actions such as seizure or injunction. The FDA emphasizes the company"s responsibility to ensure compliance with the FD&C Act, PHS Act, and applicable regulations.