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Hoosier State Today

Tuesday, November 5, 2024

Indiana: Biologics companies were the second most FDA inspected companies in Indiana in Q1

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

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

In the first quarter of 2024, five Biologics companies received five 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 29.4% of all inspections in the first quarter of 2024.

Of all the Indiana companies involved in the Biologics sector, Community Fertility Specialty Care received the most citations from the FDA 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 Indiana During Q1
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products5----
Compliance: Devices1----
Drug Quality Assurance11--
Food Composition, Standards, Labeling and Econ22--
Foodborne Biological Hazards16--
Human Cellular, Tissue, and Gene Therapies--1--
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Postmarket Assurance: Devices1----

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