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Kaleido Biosciences, Inc. was cited for failing to comply with federal regulations governing the conduct of clinical investigations for their investigational drug KB109, which was being studied in COVID-19 patients under two protocols. During a February-March 2021 FDA inspection as part of the Bioresearch Monitoring Program, investigators identified violations of 21 CFR Part 312 and the Federal Food, Drug, and Cosmetic Act, including a failure to submit Investigational New Drug (IND) applications for the clinical studies. The inspection evaluated whether the company adequately protected the rights, safety, and welfare of human subjects participating in the research.