Kaleido Biosciences, Inc.

Warning LetterOpen

Daniel Menichella Chief Executive Officer Kaleido Biosciences, Inc. 65 Hayden Avenue Lexington , MA 02421-7994 United States (b)(6)FEI 3012884265Issued Aug 26, 2021Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012884265.

Violations3

Issue DateAug 26, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Kaleido Biosciences, Inc.
Location: Daniel Menichella Chief Executive Officer Kaleido Biosciences, Inc. 65 Hayden Avenue Lexington , MA 02421-7994 United States (b)(6)
FEI Number: 3012884265
Country: United States
Issue Date: August 26, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

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.

Kaleido Biosciences, Inc. FDA Warning Letter, August 26, 2021