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Saturday, September 28, 2024

Which type of Kentucky companies were inspected the most by FDA in April?

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In April, two Biologics companies received two FDA inspections in Kentucky, 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 Kentucky, equalling 66.7% of all inspections in April.

Of all the Kentucky companies involved in Biologics, Alpha Orthopedic Systems, LLC received the most citations from the FDA in April.

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 April
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products1----
Human Cellular, Tissue, and Gene Therapies--1--
Technical Assistance: Food and Cosmetics1----

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