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Saturday, November 23, 2024

Which type of Indiana companies were inspected the most by FDA in Q1 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 first quarter of 2023, 12 Biologics companies received 12 FDA inspections in Indiana, according to the U.S. Food and Drug Administration (FDA).

This was the highest number of inspections per type of company made by the FDA in Indiana, equalling 35.3% of all inspections in the first quarter of 2023.

Of all the Indiana companies involved in the Biologics sector, Reproductive Services Of Indiana, Inc. received the most citations from the FDA in the first 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 Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring--1--
Blood and Blood Products11----
Compliance: Devices2----
Drug Quality Assurance3--1
Food Composition, Standards, Labeling and Econ1----
Foodborne Biological Hazards73--
Human Cellular, Tissue, and Gene Therapies31--
Monitoring of Marketed Animal Drugs, Feed, and Devices22--
Postmarket Assurance: Devices2----
Vaccines and Allergenic Products12----

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