FDA Warning Letter: Missing Licence and other CGMP Violations for Biologicals

From 11 to 15 September 2023, the FDA carried out an inspection of BioStem Life Sciences' facility in Florida. The company was found to be manufacturing cellular products from human umbilical cord, as well as a product combining amniotic membrane and amniotic fluid.

The FDA determined that these products are considered drugs and biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act). They are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or to affect the structure or function of the body. For example, NEOFYL® is advertised on the company website with statements such as:

“Instead of treating pain and injury with surgery and drugs, regenerative medicine supplements your body’s own healing system with natural growth factors, cytokines, collagens, and other proteins. This array of components helps cushion and support damaged tissue and joints while providing structure and ideal microenvironment conditions for rebuilding.”

Such statements indicate that the products are intended to be used for therapeutic purposes, which makes them drugs and biological products requiring FDA approval. Because BioStem Life Sciences does not have a valid Biologics Licence Application (BLA) for these products, they are considered unapproved new drugs and unlicensed biological products.

In addition, the FDA found significant violations of the CGMP regulations set forth in 21 CFR Parts 210 and 211. These violations include, but are not limited to:

• Faulty aseptic processing: the company did not implement validated procedures for aseptic processing, increasing the risk of microbial contamination.
• Inadequate quality control systems: There is a lack of established procedures for checking the quality and purity of manufactured products.
• Inadequate documentation: Key manufacturing processes and controls are not adequately documented, which affects product traceability and consistency.

The FDA requires the company to explain in writing within 15 working days what measures have been taken to rectify the identified violations and prevent their recurrence. Failure to do so may result in legal action, including seizure of the products or injunctions.

This Warning Letter emphasises the importance of classification and compliance with regulatory standards in the manufacture of biological products to ensure safety and efficacy for consumers. Read the full Warning Letter on the FDA website.