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Hoosier State Today

Tuesday, November 5, 2024

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

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Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website

In 2023, 13 device companies received 13 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 9.8% of all inspections in 2023.

Of all the Indiana companies involved in the device sector, Johns Dental Laboratories, Inc. received the most citations from the FDA in 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 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring41--
Blood and Blood Products134--
Compliance: Devices481
Drug Quality Assurance442
Food Composition, Standards, Labeling and Econ92--
Foodborne Biological Hazards50121
Human Cellular, Tissue, and Gene Therapies44--
Monitoring of Marketed Animal Drugs, Feed, and Devices1162
Postmarket Assurance: Devices10----
Vaccines and Allergenic Products121--

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