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Saturday, May 4, 2024

Virginia: Biologics companies were the second most FDA inspected companies in Virginia in 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In 2023, 26 Biologics companies received 26 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 22% of all inspections in 2023.

Of all the Virginia companies involved in the Biologics sector, The New Hope Center For Reproductive Medicine received the most citations from the FDA in 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 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring14----
Blood and Blood Products1451
Compliance: Devices55--
Drug Quality Assurance14--
Food Composition, Standards, Labeling and Econ92--
Foodborne Biological Hazards446--
Human Cellular, Tissue, and Gene Therapies631
Postmarket Assurance: Devices81--
Technical Assistance: Food and Cosmetics113--
Vaccines and Allergenic Products421

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