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Maryland State Wire

Tuesday, April 22, 2025

Maryland: Biologics companies were the second most FDA inspected companies in Maryland in 2024

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

In 2024, 24 Biologics companies received 24 FDA inspections in Maryland, 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 Maryland, equalling 15.9% of all inspections in 2024.

Of all the Maryland companies involved in the Biologics sector, Department of Defense - Navy received the most citations from the FDA in 2024.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

Top 10 FDA Inspections by Number of Actions Indicated in Maryland During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring191
Blood and Blood Products103
Compliance: Devices93
Drug Quality Assurance210
Food Composition, Standards, Labeling and Econ282
Foodborne Biological Hazards5725
Human Cellular, Tissue, and Gene Therapies61
Postmarket Assurance: Devices71
Technical Assistance: Food and Cosmetics52
Tobacco Post-Market Activities11

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