FDA WARNING_LETTER - Center for Immunology Science, LLC - November 20, 2024

The FDA issued a Warning Letter to Center For Immunology Science, LLC on January 13, 2026, following an inspection conducted between October 7 and November 20, 2024. The inspection revealed that the company, acting as a sponsor, failed to comply with applicable statutory requirements under the Federal Food, Drug, and Cosmetic Act and regulations in 21 CFR Part 312, which govern clinical investigations and human subject protection. The primary violation was the company"s failure to submit and have in effect an Investigational New Drug (IND) application before initiating clinical investigation Protocol CISMX-001, involving heat-killed *Mycobacteria smegmatis*. The Center for Immunology Science asserted the product was a dietary supplement; however, the FDA determined it was intended for use as a drug, given its study for treating or mitigating immune-deficiency diseases in 200 human subjects, thus requiring an IND. The company"s November 27, 2024, response to the inspection observations was deemed inadequate, as it lacked sufficient details for a corrective and preventive action plan to ensure future compliance with IND regulations. The FDA requires the company to address these deficiencies and demonstrate a plan to adhere to all applicable IND requirements.