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Hoosier State Today

Tuesday, November 5, 2024

FDA Inspection: What type of Indiana companies were under most scrutiny during Q4 2023?

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

In the fourth quarter of 2023, 11 Food and Cosmetics companies received 11 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 45.8% of all inspections in the fourth quarter of 2023.

Of all the Indiana companies involved in the Food and Cosmetics sector, Endangered Species Chocolate, LLC received the most citations from the FDA in the fourth 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 Q4 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products11--
Colors and Cosmetics Technology1----
Compliance: Devices--4--
Drug Quality Assurance--11
Food Composition, Standards, Labeling and Econ--1--
Foodborne Biological Hazards92--
Human Cellular, Tissue, and Gene Therapies--1--
Monitoring of Marketed Animal Drugs, Feed, and Devices22--
Postmarket Assurance: Devices3----
Vaccines and Allergenic Products--1--

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