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Monday, April 21, 2025

FDA conducted third highest number of inspections on device companies in North Carolina during 2024

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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 2024, 27 device companies received 27 FDA inspections in North Carolina, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in North Carolina, equalling 13.5% of all inspections in 2024.

Of all the North Carolina companies involved in the device sector, General Hospital Supply Corporation 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 North Carolina During 2024
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring303
Blood and Blood Products246
Compliance: Devices6111
Drug Quality Assurance152
Food Composition, Standards, Labeling and Econ195
Foodborne Biological Hazards55221
Human Cellular, Tissue, and Gene Therapies152
Monitoring of Marketed Animal Drugs, Feed, and Devices31
Postmarket Assurance: Devices112
Technical Assistance: Food and Cosmetics93

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