Device companies rank as second least inspected by FDA in Kentucky in 2025

Sara Brenner, Principal Deputy Commissioner at FDA
Sara Brenner, Principal Deputy Commissioner at FDA
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In 2025, the FDA inspected 10 device companies across Kentucky, conducting a total of 10 inspections, according to the U.S. Food and Drug Administration (FDA).

This inspection count represented the second lowest number among company types reviewed by the FDA in Kentucky, accounting for 7.1% of all inspections conducted in 2025.

Within Kentucky’s device sector, QED, Inc. and Monoprice, Inc. were the companies that received the highest number of citations from the FDA in 2025.

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 and quality.

Top 10 FDA Inspections by Number of Actions Indicated in Kentucky During 2025
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring7——
Blood and Blood Products44—
Colors and Cosmetics Technology21—
Compliance: Devices62—
Drug Quality Assurance36—
Food Composition, Standards, Labeling and Econ171—
Foodborne Biological Hazards72103
Human Cellular, Tissue, and Gene Therapies2—1
Monitoring of Marketed Animal Drugs, Feed, and Devices46—
Postmarket Assurance: Devices5——
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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