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Thursday, September 19, 2024

New Jersey: Biologics companies were the least FDA inspected companies in New Jersey in Q2

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the second quarter of 2024, three Biologics companies received three FDA inspections in New Jersey, 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 New Jersey, equalling 8.8% of all inspections in the second quarter of 2024.

Of all the New Jersey companies involved in the Biologics sector, Regional Women's Health Group, LLC received the most citations from the FDA in the second 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 Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products1----
Drug Quality Assurance22--
Food Composition, Standards, Labeling and Econ91--
Foodborne Biological Hazards214--
Human Cellular, Tissue, and Gene Therapies21--

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