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Saturday, December 28, 2024

FDA conducted lowest number of inspections on Biologics companies in Indiana during Q2 2023

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

In the second quarter of 2023, two Biologics 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 6.3% of all inspections in the second quarter of 2023.

Of all the Indiana companies involved in the Biologics sector, BHC, LLC 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.

Top 10 FDA Inspections by Number of Actions Indicated in Indiana During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring3----
Blood and Blood Products--1--
Colors and Cosmetics Technology1----
Compliance: Devices121
Drug Quality Assurance11--
Food Composition, Standards, Labeling and Econ3----
Foodborne Biological Hazards121--
Human Cellular, Tissue, and Gene Therapies--1--
Monitoring of Marketed Animal Drugs, Feed, and Devices322
Postmarket Assurance: Devices3----

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