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Monday, May 6, 2024

Virginia: Biologics companies were the second most FDA inspected companies in Virginia in Q3 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 third quarter of 2023, 10 Biologics companies received 10 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 23.8% of all inspections in the third quarter of 2023.

Of all the Virginia companies involved in the Biologics sector, American Red Cross and The American National Red Cross received the most citations from the FDA in the third 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.

FDA Inspections in Virginia During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring5----
Blood and Blood Products62--
Compliance: Devices12--
Food Composition, Standards, Labeling and Econ41--
Foodborne Biological Hazards222--
Human Cellular, Tissue, and Gene Therapies1----
Postmarket Assurance: Devices3----
Technical Assistance: Food and Cosmetics31--
Vaccines and Allergenic Products1----

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