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Thursday, October 31, 2024

New York: Devices companies were the second most FDA inspected companies in New York in December 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 December 2023, seven Devices companies received seven 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 14.6% of all inspections in December 2023.

Of all the New York companies involved in Devices, You First Services, Inc. received the most citations from the FDA in December 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.

FDA inspections in New York during December 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring2----
Blood and Blood Products12--
Compliance: Devices32--
Drug Quality Assurance12--
Food Composition, Standards, Labeling and Econ--1--
Foodborne Biological Hazards2310--
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Postmarket Assurance: Devices5----

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