FDA Inspection 1136286 — Kaleido Biosciences, Inc.
The FDA completed an inspection of Kaleido Biosciences, Inc. on Mar 3, 2021 in Lexington, MA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 3, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Lexington, MA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |