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Friday, November 1, 2024

FDA conducted second highest number of inspections on Biologics companies in Virginia during Q2 2023

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In the second quarter of 2023, four Biologics companies received four FDA inspections in Virginia, 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 Virginia, equalling 12.9% of all inspections in the second quarter of 2023.

Of all the Virginia companies involved in the Biologics sector, VCU Health System Reproductive Medicine and IVF 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 Virginia During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products21--
Compliance: Devices1----
Drug Quality Assurance--2--
Food Composition, Standards, Labeling and Econ4----
Foodborne Biological Hazards142--
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices21--
Technical Assistance: Food and Cosmetics41--
Tobacco Post-Market Activities2----

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