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Hoosier State Today

Tuesday, November 5, 2024

FDA conducted lowest number of inspections on Drugs companies in Indiana during Q3 2023

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

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

This was the lowest number of inspections per type of company made by the FDA in Indiana, equalling 4.8% of all inspections in the third quarter of 2023.

Of all the Indiana companies involved in the Drugs sector, AstraZeneca Pharmaceuticals LP 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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