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Wednesday, September 18, 2024

New York: Device companies were the third most FDA inspected companies in New York in Q2

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In the second quarter of 2024, four device companies received four 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 5.9% of all inspections in the second 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 Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring31--
Blood and Blood Products62--
Compliance: Devices2----
Drug Quality Assurance--1--
Food Composition, Standards, Labeling and Econ41--
Foodborne Biological Hazards2813--
Human Cellular, Tissue, and Gene Therapies63--
Monitoring of Marketed Animal Drugs, Feed, and Devices11--
Postmarket Assurance: Devices2----
Technical Assistance: Food and Cosmetics55--

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