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Thursday, October 31, 2024

New York: Device companies were the second most FDA inspected companies in New York in Q2 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the second quarter of 2023, 14 device companies received 14 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 13.5% of all inspections in the second quarter of 2023.

Of all the New York companies involved in the device sector, Turbett Surgical, Inc. received the most citations from the FDA in the second 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 Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring181--
Blood and Blood Products53--
Compliance: Devices34--
Drug Quality Assurance11--
Food Composition, Standards, Labeling and Econ11--
Foodborne Biological Hazards42161
Human Cellular, Tissue, and Gene Therapies42--
Monitoring of Marketed Animal Drugs, Feed, and Devices25--
Postmarket Assurance: Devices31--
Technical Assistance: Food and Cosmetics11--

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