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Tuesday, November 5, 2024

FDA conducted lowest number of inspections on device companies in Utah during Q1 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

In the first quarter of 2023, three device companies received three FDA inspections in Utah, 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 Utah, equalling 14.3% of all inspections in the first quarter of 2023.

Of all the Utah companies involved in the device sector, SteriGear, LLC 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.

FDA Inspections in Utah During Q1 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring31--
Blood and Blood Products31--
Compliance: Devices21--
Food Composition, Standards, Labeling and Econ321
Foodborne Biological Hazards36--
Human Cellular, Tissue, and Gene Therapies--2--
Postmarket Assurance: Devices2----
Vaccines and Allergenic Products3----

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