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Sunday, December 22, 2024

FDA conducted third highest number of inspections on Biologics companies in North Carolina during Q3 2023

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Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

In the third quarter of 2023, 10 Biologics companies received 10 FDA inspections in North Carolina, according to the U.S. Food and Drug Administration (FDA).

This was the third highest number of inspections per type of company made by the FDA in North Carolina, equalling 19.2% of all inspections in the third 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 Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring6----
Blood and Blood Products8----
Compliance: Devices72--
Drug Quality Assurance--3--
Food Composition, Standards, Labeling and Econ113--
Foodborne Biological Hazards137--
Human Cellular, Tissue, and Gene Therapies2----
Monitoring of Marketed Animal Drugs, Feed, and Devices--1--
Postmarket Assurance: Devices9----
Tobacco Post-Market Activities3----

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