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Thursday, November 21, 2024

FDA conducted third lowest number of inspections on Drugs companies in New York during Q2

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

In the second quarter of 2024, three Drugs companies received three FDA inspections in New York, according to the U.S. Food and Drug Administration (FDA).

This was the third lowest number of inspections per type of company made by the FDA in New York, equalling 4.4% of all inspections in the second quarter of 2024.

Of all the New York companies involved in the Drugs sector, American Regent, Inc. received the most citations from the FDA 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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