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

Source: https://www.keypedia.com/records/483/kaleido-biosciences-inc/0de44820-fdcf-47c8-bfdf-b6d47b2bc1ad

> FDA 483 for Kaleido Biosciences, Inc. on March 03, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kaleido Biosciences, Inc.
- Inspection Date: 2021-03-03
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2021-03-03](https://www.keypedia.com/records/warning_letter/kaleido-biosciences-inc/7233646a-f340-4855-bb1d-77249fb63b59)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.keypedia.com/companies/kaleido-biosciences-inc/35883bee-925a-483a-ac90-c2efb44e0ccb

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94