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Wednesday, November 13, 2024

North Carolina: Device companies were the second least FDA inspected companies in North Carolina in Q3

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Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website

In the third quarter of 2024, two device companies received two FDA inspections in North Carolina, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in North Carolina, equalling 7.7% of all inspections in the third quarter of 2024.

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.

Top 10 FDA Inspections by Number of Actions Indicated in North Carolina During Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products51--
Colors and Cosmetics Technology1----
Compliance: Devices1----
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ5----
Foodborne Biological Hazards93--
Human Cellular, Tissue, and Gene Therapies2----
Postmarket Assurance: Devices1----
Tobacco Post-Market Activities1----

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