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Thursday, September 19, 2024

North Carolina: Device companies were the second least FDA inspected companies in North Carolina in Q2

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the second quarter of 2024, five device companies received five 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 20.8% of all inspections in the second quarter of 2024.

Of all the North Carolina companies involved in the device sector, General Hospital Supply Corporation received the most citations from the FDA in the second 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 Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products51--
Compliance: Devices22--
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ3----
Foodborne Biological Hazards72--
Human Cellular, Tissue, and Gene Therapies3----
Postmarket Assurance: Devices3----
Technical Assistance: Food and Cosmetics1----
Tobacco Post-Market Activities1----

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