FDA inspection
Magellan Diagnostics, Inc.: FDA inspection ending Aug 26, 2025
FDA inspection 1280392 · Official Action Indicated (OAI) · North Billerica, MA
Key facts
| Inspection ID | 1280392 |
|---|---|
| Firm | Magellan Diagnostics, Inc. |
| FEI number | 1218996 |
| Address | 101 Billerica Ave Bldg 4 |
| City | North Billerica |
| State | MA |
| ZIP | 01862 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Aug 26, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 720826 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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