Orca1

FDA inspection

Foundation Medicine, Inc.: FDA inspection ending Feb 14, 2020

FDA inspection 1119282 · No Action Indicated (NAI) · Cambridge, MA

Key facts

Inspection ID 1119282
Firm Foundation Medicine, Inc.
FEI number 3010679023
Address 150 2nd St
City Cambridge
State MA
ZIP 02141-2115
Fiscal year 2020
Inspection end date Feb 14, 2020
Classification No Action Indicated (NAI)
Project area Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical 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

Browse all FDA inspections