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Monday, November 4, 2024

FDA Inspection: What type of Kentucky companies were under most scrutiny during Q2 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 second quarter of 2023, 10 Food and Cosmetics companies received 10 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 47.6% of all inspections in the second quarter of 2023.

Of all the Kentucky companies involved in the Food and Cosmetics sector, PI Pharma, Inc. received the most citations from the FDA in the second 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 Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring11--
Compliance: Devices--1--
Food Composition, Standards, Labeling and Econ--1--
Foodborne Biological Hazards73--
Monitoring of Marketed Animal Drugs, Feed, and Devices53--
Postmarket Assurance: Devices--1--
Technical Assistance: Food and Cosmetics21--

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