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Thursday, November 21, 2024

North Carolina: Devices companies were the second most FDA inspected companies in North Carolina in December 2023

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In December 2023, two Devices companies received two FDA inspections in North Carolina, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in North Carolina, equalling 20% of all inspections in December 2023.

Of all the North Carolina companies involved in Devices, WatchChild, LLC and Tex-Care Medical received the most citations from the FDA in December 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.

FDA inspections in North Carolina during December 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products--1--
Compliance: Devices--2--
Drug Quality Assurance1----
Food Composition, Standards, Labeling and Econ3----
Foodborne Biological Hazards5----
Postmarket Assurance: Devices1----

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