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Tuesday, December 3, 2024

FDA Inspection: What type of Connecticut companies were under most scrutiny during Q4 2023?

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

In the fourth quarter of 2023, four Biologics companies received four FDA inspections in Connecticut, according to the U.S. Food and Drug Administration (FDA).

This was the highest number of inspections per type of company made by the FDA in Connecticut, equalling 36.4% of all inspections in the fourth 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 Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products3----
Colors and Cosmetics Technology1----
Compliance: Devices21--
Foodborne Biological Hazards3----
Human Cellular, Tissue, and Gene Therapies3----
Postmarket Assurance: Devices21--

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