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Thursday, November 21, 2024

New Jersey: Device companies were the second most FDA inspected companies in New Jersey in Q3 2023

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In the third quarter of 2023, 16 device companies received 16 FDA inspections in New Jersey, 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 New Jersey, equalling 16% of all inspections in the third quarter of 2023.

Of all the New Jersey companies involved in the device sector, Light Age, Inc. received the most citations from the FDA 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 New Jersey During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring52--
Blood and Blood Products3----
Compliance: Devices67--
Drug Quality Assurance351
Food Composition, Standards, Labeling and Econ122--
Foodborne Biological Hazards45111
Human Cellular, Tissue, and Gene Therapies21--
Monitoring of Marketed Animal Drugs, Feed, and Devices12--
Postmarket Assurance: Devices101--
Technical Assistance: Food and Cosmetics2----

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