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Monday, November 4, 2024

FDA conducted third highest number of inspections on Biologics companies in Kentucky during Q4 2023

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

This was the third highest number of inspections per type of company made by the FDA in Kentucky, equalling 14.3% 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 Kentucky During Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products1----
Compliance: Devices1----
Drug Quality Assurance1----
Foodborne Biological Hazards5----
Monitoring of Marketed Animal Drugs, Feed, and Devices3----
Tobacco Post-Market Activities11--

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