Warning letter
Stephen J. Fallon, Ph.D.: warning letter of Aug 27, 2026
FDA warning letter 728673 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 728673 |
|---|---|
| Company | Stephen J. Fallon, Ph.D. |
| Subject | Bioresearch Monitoring Program/Institutional Review Board (IRB) |
| Issue date | Aug 27, 2026 |
| Posted date | Sep 8, 2026 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 50, 50.20, 50.25, 50.27, 50.27(a), 812, 812.100, 812.110(b), 812.140(a)(2) |
| Inspection city | Wilton Manors |
| Inspection ZIP | 33305-1321 |
| Inspection start date | Jun 2, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: