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Friday, April 25, 2025

FDA conducted second lowest number of inspections on device companies in Illinois during 2024

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

In 2024, 23 device companies received 24 FDA inspections in Illinois, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in Illinois, equalling 7.7% of all inspections in 2024.

Of all the Illinois companies involved in the device sector, Stericycle, Inc. received the most citations from the FDA in 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.

Top 10 FDA Inspections by Number of Actions Indicated in Illinois During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring253
Blood and Blood Products306
Compliance: Devices1081
Drug Quality Assurance126
Food Composition, Standards, Labeling and Econ235
Foodborne Biological Hazards112345
Human Cellular, Tissue, and Gene Therapies72
Monitoring of Marketed Animal Drugs, Feed, and Devices3482
Postmarket Assurance: Devices133
Technical Assistance: Food and Cosmetics131

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