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Thursday, November 21, 2024

Connecticut: Biologics companies were the second most FDA inspected companies in Connecticut in 2023

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In 2023, 12 Biologics companies received 12 FDA inspections in Connecticut, 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 Connecticut, equalling 27.3% of all inspections in 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 Connecticut During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring41--
Blood and Blood Products8----
Colors and Cosmetics Technology1----
Compliance: Devices75--
Food Composition, Standards, Labeling and Econ22--
Foodborne Biological Hazards133--
Human Cellular, Tissue, and Gene Therapies6----
Postmarket Assurance: Devices92--
Technical Assistance: Food and Cosmetics2----
Vaccines and Allergenic Products2----

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