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Thursday, September 19, 2024

FDA conducted lowest number of inspections on device companies in North Carolina during Q1

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

This was the lowest number of inspections per type of company made by the FDA in North Carolina, equalling 15% of all inspections in the first 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.

FDA Inspections in North Carolina During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products31--
Compliance: Devices21--
Drug Quality Assurance111
Food Composition, Standards, Labeling and Econ11--
Foodborne Biological Hazards52--
Human Cellular, Tissue, and Gene Therapies1----
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics2----

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