FDA inspection

Exact Sciences Corporation: FDA inspection ending Apr 5, 2024

FDA inspection 1237547 · No Action Indicated (NAI) · Madison, Wisconsin

Key facts

Inspection ID 1237547
Firm Exact Sciences Corporation
FEI number 3015728010
Address 650 Forward Dr
City Madison
State Wisconsin
ZIP 53711
Fiscal year 2024
Inspection end date Apr 5, 2024
Classification No Action Indicated (NAI)
Project area Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: 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.

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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