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Sunday, May 5, 2024

FDA conducted third highest number of inspections on device companies in New Jersey during 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In 2023, 33 device companies received 33 FDA inspections in New Jersey, 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 New Jersey, equalling 10.3% of all inspections in 2023.

Of all the New Jersey companies involved in the device sector, Light Age, Inc. received the most citations from the FDA in 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 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring135--
Blood and Blood Products113--
Compliance: Devices918--
Drug Quality Assurance10164
Food Composition, Standards, Labeling and Econ414--
Foodborne Biological Hazards143592
Human Cellular, Tissue, and Gene Therapies63--
Monitoring of Marketed Animal Drugs, Feed, and Devices63--
Postmarket Assurance: Devices153--
Vaccines and Allergenic Products3----

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