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Monday, September 30, 2024

Indiana: Biologics companies were the second most FDA inspected companies in Indiana in Q3 2023

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

In the third quarter of 2023, four Biologics companies received four FDA inspections in Indiana, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Indiana, equalling 9.5% of all inspections in the third quarter of 2023.

Of all the Indiana companies involved in the Biologics sector, Advanced Reproductive Health Center, Chicago IVF, Ltd. received the most citations from the FDA in the third 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.

Top 10 FDA Inspections by Number of Actions Indicated in Indiana During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring1----
Blood and Blood Products12--
Colors and Cosmetics Technology1----
Compliance: Devices12--
Food Composition, Standards, Labeling and Econ51--
Foodborne Biological Hazards2261
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices4----
Postmarket Assurance: Devices2----
Technical Assistance: Food and Cosmetics3----

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