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Maryland State Wire

Wednesday, April 23, 2025

Maryland: Device companies were the third least FDA inspected companies in Maryland in 2024

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

In 2024, 16 device companies received 16 FDA inspections in Maryland, according to the U.S. Food and Drug Administration (FDA).

This was the third lowest number of inspections per type of company made by the FDA in Maryland, equalling 10.6% of all inspections in 2024.

Of all the Maryland companies involved in the device sector, Aerscher Diagnostics, LLC 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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