Warning letter
Kaleido Biosciences, Inc.: warning letter of Aug 26, 2021
FDA warning letter 616026 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 616026 |
|---|---|
| Company | Kaleido Biosciences, Inc. |
| Subject | Bioresearch Monitoring Program |
| Issue date | Aug 26, 2021 |
| Posted date | Sep 7, 2021 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 312, 312.2, 312.20, 312.40, 312.2(a), 312.20(a) |
| Inspection city | Lexington |
| Inspection ZIP | 02421 |
| Inspection start date | Feb 24, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: