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Center for Immunology Science, LLC failed to submit a required Investigational New Drug (IND) application before conducting a clinical investigation with heat-killed Mycobacteria smegmatis, a product intended as a nutritional supplement/biotic to boost immune system and microbiome health. The FDA's Bioresearch Monitoring Program inspection conducted from October 7 to November 20, 2024 identified violations of 21 CFR 312 regulations governing clinical investigations and human subject protection. The company did not comply with statutory requirements under the Federal Food, Drug, and Cosmetic Act regarding the initiation and conduct of the clinical investigation (Protocol CISMX-001/CISMX-001B).