Warning letter
Sanofi-Synthelabo, Inc.: warning letter of Sep 21, 2001
FDA warning letter UCM178720 · New York District Office
Key facts
| Reference number | UCM178720 |
|---|---|
| Company | Sanofi-Synthelabo, Inc. |
| Subject | Postmarketing Adverse Drug Experience Reporting Requirements |
| Issue date | Sep 21, 2001 |
| Posted date | Sep 21, 2001 |
| Issuing office | New York District Office |
| Product type | Drugs |
| CFR sections cited | 314.80, 314.80(c) |
| Country | 3 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
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: