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Friday, September 20, 2024

FDA conducted second lowest number of inspections on Biologics companies in New Jersey during 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 2024, four Biologics companies received four FDA inspections in New Jersey, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in New Jersey, equalling 6.7% 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 New Jersey During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring--1--
Blood and Blood Products4----
Drug Quality Assurance42--
Food Composition, Standards, Labeling and Econ911
Foodborne Biological Hazards3412--
Human Cellular, Tissue, and Gene Therapies2----
Technical Assistance: Food and Cosmetics--1--
Tobacco Post-Market Activities1----

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