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Monday, April 21, 2025

North Carolina: Biologics companies were the second most FDA inspected companies in North Carolina in Q1

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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 2025, 15 Biologics companies received 15 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 42.9% of all inspections in the first quarter of 2025.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

FDA Inspections in North Carolina During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products10
Drug Quality Assurance1
Food Composition, Standards, Labeling and Econ62
Foodborne Biological Hazards95
Human Cellular, Tissue, and Gene Therapies5
Monitoring of Marketed Animal Drugs, Feed, and Devices11
Technical Assistance: Food and Cosmetics11
Tobacco Post-Market Activities1

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