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