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Thursday, November 21, 2024

North Carolina: Device companies were the third least FDA inspected companies in North Carolina in Q1 2023

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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 first quarter of 2023, nine device companies received nine FDA inspections in North Carolina, 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 North Carolina, equalling 14.5% of all inspections in the first quarter of 2023.

Of all the North Carolina companies involved in the device sector, REACT Innovations received the most citations from the FDA in the first quarter of 2023.

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 Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring101--
Blood and Blood Products10----
Compliance: Devices16--
Drug Quality Assurance--2--
Food Composition, Standards, Labeling and Econ91--
Foodborne Biological Hazards2051
Human Cellular, Tissue, and Gene Therapies21--
Postmarket Assurance: Devices52--
Tobacco Post-Market Activities4----
Vaccines and Allergenic Products10----

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