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Buckeye Reporter

Thursday, November 21, 2024

FDA conducted second lowest number of inspections on Biologics companies in Ohio during Q2 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 second quarter of 2023, nine Biologics companies received nine FDA inspections in Ohio, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in Ohio, equalling 10.7% of all inspections in the second quarter of 2023.

Of all the Ohio companies involved in the Biologics sector, Richard B. Powell, M.D. received the most citations from the FDA in the second 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 Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring81--
Blood and Blood Products7----
Compliance: Devices85--
Drug Quality Assurance21--
Food Composition, Standards, Labeling and Econ321
Foodborne Biological Hazards2671
Human Cellular, Tissue, and Gene Therapies3----
Monitoring of Marketed Animal Drugs, Feed, and Devices105--
Postmarket Assurance: Devices6----
Technical Assistance: Food and Cosmetics5----

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