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Sunday, December 22, 2024

FDA conducted second highest number of inspections on device companies in New York during Q3 2023

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

In the third quarter of 2023, 11 device companies received 11 FDA inspections in New York, 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 York, equalling 9.2% of all inspections in the third quarter of 2023.

Of all the New York companies involved in the device sector, Banyan USA, LLC 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 York During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring9----
Blood and Blood Products82--
Compliance: Devices37--
Drug Quality Assurance221
Food Composition, Standards, Labeling and Econ43--
Foodborne Biological Hazards4722--
Human Cellular, Tissue, and Gene Therapies42--
Monitoring of Marketed Animal Drugs, Feed, and Devices26--
Postmarket Assurance: Devices81--
Technical Assistance: Food and Cosmetics6----

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