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# ‘Objectionable Conditions’ Found in Kaleido Inspection
- URL: https://www.fdaweb.com/objectionable-conditions-found-in-kaleido-inspection/
- Published: 2021-09-07T12:00:00.000Z
- Updated: 2026-09-14T17:13:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150086

A 2/24-3/3 FDA inspection at Kaleido Bioscience, Lexington, MA, found “objectionable conditions” in the firm’s role as sponsor of clinical investigations for the investigational drug KB109\. An 8/26 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kaleido-biosciences-inc-616026-08262021?ref=fdaweb.com) says the inspection was part of the FDA Bioresearch Monitoring Program and found that Kaleido did not adhere to applicable statutory requirements and regulations governing the conduct of clinical investigations and the protection of human subjects.

The letter says Kaleido failed to submit INDs for the conduct of two clinical investigations with an investigational new drug. The letter says the company first asserted that it was not obligated to submit an IND before starting the studies because KB109 was a food rather than a drug.

FDA says that because Kaleido was studying the efficacy and safety of KB109 to mitigate and treat Covid-19 in patients who test positive for Covid-19, the product is legally considered to be a drug.

The letter says Kaleido said it was developing a procedure for determining the need for an IND when developing protocols for applicable clinical studies but did not provide sufficient details about the new procedure to enable the agency to determine whether the corrective action plan is adequate to prevent similar violations in the future.

Kaleido was told to respond with a list of actions it has taken to prevent similar violations in the future or justification for its belief that it complies with the law and regulations.