FDA inspection
REGENXBIO Inc: FDA inspection ending Aug 4, 2025
FDA inspection 1298212 · No Action Indicated (NAI) · Rockville, MD
Key facts
| Inspection ID | 1298212 |
|---|---|
| Firm | REGENXBIO Inc |
| FEI number | 3012957259 |
| Address | 9804 Medical Center Dr |
| City | Rockville |
| State | MD |
| ZIP | 20850-4511 |
| Fiscal year | 2025 |
| Inspection end date | Aug 4, 2025 |
| Classification | No Action Indicated (NAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics, Drugs |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data