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Thursday, November 21, 2024

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

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

In 2023, 12 Biologics companies received 12 FDA inspections in Kansas, 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 Kansas, equalling 9.8% of all inspections in 2023.

Of all the Kansas companies involved in the Biologics sector, Lisa A. Clough, M.D. and KUPI Reproductive Endocrinology & Infertility Lab received the most citations from the FDA in 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.

Top 10 FDA Inspections by Number of Actions Indicated in Kansas During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring52--
Blood and Blood Products91--
Compliance: Devices44--
Drug Quality Assurance--11
Food Composition, Standards, Labeling and Econ5--1
Foodborne Biological Hazards415--
Human Cellular, Tissue, and Gene Therapies51--
Monitoring of Marketed Animal Drugs, Feed, and Devices3851
Postmarket Assurance: Devices8----
Technical Assistance: Food and Cosmetics3----

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