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Saturday, June 14, 2025

FDA conducted third highest number of inspections on device companies in Illinois during Q4 2024

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the fourth quarter of 2024, five device companies received five FDA inspections in Illinois, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in Illinois, equalling 12.2% of all inspections in the fourth quarter of 2024.

Of all the Illinois companies involved in the device sector, Coapt, LLC received the most citations from the FDA in the fourth quarter of 2024.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

FDA Inspections in Illinois During Q4 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring31
Blood and Blood Products82
Compliance: Devices23
Drug Quality Assurance1
Foodborne Biological Hazards152
Monitoring of Marketed Animal Drugs, Feed, and Devices21
Postmarket Assurance: Devices5
Technical Assistance: Food and Cosmetics4
Tobacco Post-Market Activities1

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