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Monday, May 13, 2024

FDA Inspection: What type of North Carolina companies were under most scrutiny during Q4 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 fourth quarter of 2023, 23 Food and Cosmetics companies received 23 FDA inspections in North Carolina, according to the U.S. Food and Drug Administration (FDA).

This was the highest number of inspections per type of company made by the FDA in North Carolina, equalling 60.5% of all inspections in the fourth quarter of 2023.

Of all the North Carolina companies involved in the Food and Cosmetics sector, 3Fish, Inc. received the most citations from the FDA in the fourth 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 Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring2----
Blood and Blood Products22--
Compliance: Devices--3--
Drug Quality Assurance1----
Food Composition, Standards, Labeling and Econ72--
Foodborne Biological Hazards138--
Human Cellular, Tissue, and Gene Therapies3----
Postmarket Assurance: Devices2----
Technical Assistance: Food and Cosmetics1----
Tobacco Post-Market Activities11--

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