FDA inspection
Fujirebio Diagnostics, Inc.: FDA inspection ending May 29, 2026
FDA inspection 1325136 · Malvern, PA
Key facts
| Inspection ID | 1325136 |
|---|---|
| Firm | Fujirebio Diagnostics, Inc. |
| FEI number | 2521625 |
| Address | 201 Great Valley Pkwy |
| City | Malvern |
| State | PA |
| ZIP | 19355-1308 |
| Fiscal year | 2026 |
| Inspection end date | May 29, 2026 |
| Product type | Devices |
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