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Thursday, October 31, 2024

FDA conducted third highest number of inspections on Biologics companies in New York during December 2023

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In December 2023, three Biologics companies received three 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 6.3% of all inspections in December 2023.

Of all the New York companies involved in Biologics, New York Blood Center Enterprises 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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