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Thursday, September 19, 2024

New York: Device companies were the third most FDA inspected companies in New York in Q1

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In the first quarter of 2024, eight device companies received eight FDA inspections in New York, 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 York, equalling 8.8% of all inspections in the first quarter of 2024.

Of all the New York companies involved in the device sector, Avox Systems, Inc., Ambulatory Monitoring, Inc., and Nalge Nunc International Corporation received the most citations from the FDA 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.

Top 10 FDA Inspections by Number of Actions Indicated in New York During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring4----
Blood and Blood Products123--
Compliance: Devices25--
Drug Quality Assurance13--
Food Composition, Standards, Labeling and Econ33--
Foodborne Biological Hazards3221--
Human Cellular, Tissue, and Gene Therapies54--
Monitoring of Marketed Animal Drugs, Feed, and Devices21--
Postmarket Assurance: Devices42--
Technical Assistance: Food and Cosmetics11--

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