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Sunday, December 22, 2024

FDA conducted third highest number of inspections on Biologics companies in Ohio during Q1 2023

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In the first 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 third highest number of inspections per type of company made by the FDA in Ohio, equalling 9.6% of all inspections in the first quarter of 2023.

Of all the Ohio companies involved in the Biologics sector, Bethesda Fertility Center received the most citations from the FDA in the first 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 Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring52--
Blood and Blood Products61--
Compliance: Devices67--
Food Composition, Standards, Labeling and Econ7--1
Foodborne Biological Hazards38112
Human Cellular, Tissue, and Gene Therapies21--
Monitoring of Marketed Animal Drugs, Feed, and Devices72--
Postmarket Assurance: Devices8----
Technical Assistance: Food and Cosmetics51--
Vaccines and Allergenic Products7----

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