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FDA inspection

FOUNDATION MEDICINE, INC.: FDA inspection ending Apr 14, 2026

FDA inspection 1313270 · No Action Indicated (NAI) · Boston, Massachusetts

Key facts

Inspection ID 1313270
Firm FOUNDATION MEDICINE, INC.
FEI number 3031598391
Address 400 Summer St
City Boston
State Massachusetts
ZIP 02210
Fiscal year 2026
Inspection end date Apr 14, 2026
Classification No Action Indicated (NAI)
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: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Project Evaluation: Devices
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.

Other inspections at this establishment

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

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