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Thursday, November 7, 2024

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

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In 2023, nine Biologics companies received nine FDA inspections in West 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 West Virginia, equalling 40.9% of all inspections in 2023.

Of all the West Virginia companies involved in the Biologics sector, American Red Cross Blood Services Appalachian Region 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.

FDA Inspections in West Virginia During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products71--
Foodborne Biological Hazards72--
Human Cellular, Tissue, and Gene Therapies3----
Technical Assistance: Food and Cosmetics4----
Tobacco Post-Market Activities1----
Vaccines and Allergenic Products21--

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