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Thursday, October 31, 2024

New York: Biologics companies were the second most FDA inspected companies in New York in Q3

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

In the third quarter of 2024, seven Biologics 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 15.9% of all inspections in the third quarter of 2024.

Of all the New York companies involved in the Biologics sector, Mount Sinai Hospital Blood Bank received the most citations from the FDA in the third 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 Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring2----
Blood and Blood Products23--
Compliance: Devices1----
Drug Quality Assurance--2--
Food Composition, Standards, Labeling and Econ24--
Foodborne Biological Hazards1910--
Human Cellular, Tissue, and Gene Therapies1----
Monitoring of Marketed Animal Drugs, Feed, and Devices1----
Postmarket Assurance: Devices1----
Technical Assistance: Food and Cosmetics2----

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