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Bluegrass Times

Tuesday, December 3, 2024

FDA Inspection: What type of Kentucky companies were under most scrutiny during August?

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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 August, one Biologics company received an FDA inspection in Kentucky, according to the U.S. Food and Drug Administration (FDA).

This represents 50% of all inspections conducted in the state in August.

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 August
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products1----
Compliance: Devices--1--
Human Cellular, Tissue, and Gene Therapies1----
Postmarket Assurance: Devices1----

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