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Sunday, May 5, 2024

FDA conducted second highest number of inspections on device companies in New York during Q4 2023

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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 fourth quarter of 2023, 16 device companies received 16 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 14% of all inspections in the fourth quarter of 2023.

Of all the New York companies involved in the device sector, Orthodent Laboratory, Inc. received the most citations from the FDA in the fourth 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 Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring4----
Blood and Blood Products44--
Compliance: Devices68--
Drug Quality Assurance25--
Food Composition, Standards, Labeling and Econ42--
Foodborne Biological Hazards4422--
Human Cellular, Tissue, and Gene Therapies42--
Monitoring of Marketed Animal Drugs, Feed, and Devices31--
Postmarket Assurance: Devices131--
Technical Assistance: Food and Cosmetics41--

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