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Buckeye Reporter

Wednesday, November 6, 2024

Ohio: Biologics companies were the third most FDA inspected companies in Ohio in Q3 2023

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the third quarter of 2023, 10 Biologics companies received 10 FDA inspections in Ohio, 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 Ohio, equalling 13.2% of all inspections in the third quarter of 2023.

Of all the Ohio companies involved in the Biologics sector, Abraham J. And Phyllis Katz Cord Blood Foundation received the most citations from the FDA in the third quarter of 2023.

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.

Top 10 FDA Inspections by Number of Actions Indicated in Ohio During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring5----
Blood and Blood Products41--
Compliance: Devices66--
Drug Quality Assurance23--
Food Composition, Standards, Labeling and Econ73--
Foodborne Biological Hazards2111--
Human Cellular, Tissue, and Gene Therapies32--
Monitoring of Marketed Animal Drugs, Feed, and Devices24--
Postmarket Assurance: Devices6----
Technical Assistance: Food and Cosmetics42--

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