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Buckeye Reporter

Wednesday, November 6, 2024

Ohio: Device companies were the least FDA inspected companies in Ohio in Q2

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Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

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

This was the lowest number of inspections per type of company made by the FDA in Ohio, equalling 7.5% of all inspections in the second quarter of 2024.

Of all the Ohio companies involved in the device sector, Apneicare, LLC and AeroBiotix, LLC received the most citations from the FDA in the second quarter of 2024.

The FDA routinely inspects facilities across the nation to determine if the workplaces and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly for businesses to consistently make smarter business decisions for the future.

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

FDA Inspections in Ohio During Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products3----
Compliance: Devices12--
Drug Quality Assurance21--
Food Composition, Standards, Labeling and Econ42--
Foodborne Biological Hazards144--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices52--
Postmarket Assurance: Devices2----
Technical Assistance: Food and Cosmetics6----

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