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Buckeye Reporter

Tuesday, September 9, 2025

Ohio: Device companies were the second most FDA inspected companies in Ohio in 2024

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

In 2024, 41 device companies received 41 FDA inspections in Ohio, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Ohio, equalling 14.2% of all inspections in 2024.

Of all the Ohio companies involved in the device sector, Transdermal Cap, 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 Ohio During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring18
Blood and Blood Products161
Compliance: Devices15201
Drug Quality Assurance571
Food Composition, Standards, Labeling and Econ137
Foodborne Biological Hazards118251
Human Cellular, Tissue, and Gene Therapies12
Monitoring of Marketed Animal Drugs, Feed, and Devices2082
Postmarket Assurance: Devices241
Technical Assistance: Food and Cosmetics183

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