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Tuesday, December 3, 2024

FDA conducted second lowest number of inspections on Biologics companies in Connecticut during Q1

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In the first quarter of 2024, two Biologics companies received two FDA inspections in Connecticut, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in Connecticut, equalling 20% of all inspections in the first 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.

FDA Inspections in Connecticut During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products1----
Colors and Cosmetics Technology1----
Compliance: Devices11--
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards2----
Human Cellular, Tissue, and Gene Therapies1----
Postmarket Assurance: Devices11--
Technical Assistance: Food and Cosmetics1----

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