FDA inspection
FOUNDATION MEDICINE, INC.: FDA inspection ending Jan 28, 2025
FDA inspection 1259315 · Official Action Indicated (OAI) · Boston, Massachusetts
Key facts
| Inspection ID | 1259315 |
|---|---|
| Firm | FOUNDATION MEDICINE, INC. |
| FEI number | 3031598391 |
| Address | 400 Summer St |
| City | Boston |
| State | Massachusetts |
| ZIP | 02210 |
| Fiscal year | 2025 |
| Inspection end date | Jan 28, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 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