FDA Inspection 1136286 — Kaleido Biosciences, Inc.

Kaleido Biosciences, Inc. — FEI 3012884265

The FDA completed an inspection of Kaleido Biosciences, Inc. on March 3, 2021 in Lexington, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 3, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Lexington, MA (United States)

Additional Details

Sponsor, Contract Research Organization

Citations

IDCFRDescription
763821 CFR 312.20(a)Failure to submit an IND