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Wednesday, January 29, 2025

Connecticut: Device companies were the second most FDA inspected companies in Connecticut in Q3 2023

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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 third quarter of 2023, four device companies received four 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 28.6% of all inspections in the third quarter of 2023.

Of all the Connecticut companies involved in the device sector, Falck Medical Incorporated received the most citations from the FDA in the third quarter of 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 Connecticut During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products3----
Compliance: Devices31--
Food Composition, Standards, Labeling and Econ11--
Foodborne Biological Hazards6----
Human Cellular, Tissue, and Gene Therapies2----
Postmarket Assurance: Devices4----
Technical Assistance: Food and Cosmetics2----

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