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Tuesday, December 3, 2024

Kentucky: Device companies were the third most FDA inspected companies in Kentucky in Q1

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the first quarter of 2024, four device companies received four 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 17.4% of all inspections in the first 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 Kentucky During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products1----
Compliance: Devices3----
Drug Quality Assurance1----
Foodborne Biological Hazards71--
Monitoring of Marketed Animal Drugs, Feed, and Devices5----
Pre-Approval Eval. of Animal Drugs and Food Additives----1
Technical Assistance: Food and Cosmetics2----
Tobacco Post-Market Activities2----

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