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Wednesday, November 13, 2024

Connecticut: Device companies were the least FDA inspected companies in Connecticut in Q3

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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 2024, three device companies received three FDA inspections in Connecticut, according to the U.S. Food and Drug Administration (FDA).

This was the lowest number of inspections per type of company made by the FDA in Connecticut, equalling 42.9% of all inspections in the third quarter of 2024.

Of all the Connecticut companies involved in the device sector, Kelyniam Global, Inc. 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.

FDA Inspections in Connecticut During Q3
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Compliance: Devices21--
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards11--
Postmarket Assurance: Devices21--
Technical Assistance: Food and Cosmetics11--

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