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Monday, April 21, 2025

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

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In 2024, 10 device companies received 10 FDA inspections in Kentucky, 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 Kentucky, equalling 9.1% of all inspections in 2024.

Of all the Kentucky companies involved in the device sector, Aquilo Sports, LLC 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 Kentucky During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring31
Blood and Blood Products6
Compliance: Devices44
Drug Quality Assurance25
Food Composition, Standards, Labeling and Econ2
Foodborne Biological Hazards4012
Human Cellular, Tissue, and Gene Therapies31
Monitoring of Marketed Animal Drugs, Feed, and Devices951
Technical Assistance: Food and Cosmetics131
Tobacco Post-Market Activities3

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