FDA inspection
Magellan Diagnostics, Inc.: FDA inspection ending Jun 29, 2017
FDA inspection 1016218 · Official Action Indicated (OAI) · North Billerica, MA
Key facts
| Inspection ID | 1016218 |
|---|---|
| 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 | 2017 |
| Inspection end date | Jun 29, 2017 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 532743 |
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