FDA 483 - Kaleido Biosciences, Inc. - March 03, 2021

An FDA inspection of Kaleido Biosciences, Inc. in Lexington, MA, revealed a critical regulatory violation regarding clinical investigations. The firm conducted two clinical studies involving investigational new drugs without first submitting an Investigational New Drug (IND) application to the FDA. This represents a serious failure to comply with regulatory requirements for human subject protection and drug development oversight.