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Saturday, May 18, 2024

Utah: Biologics companies were the second most FDA inspected companies in Utah in 2023

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Vid Desai FDA’s Chief Information Officer | Official Website

Vid Desai FDA’s Chief Information Officer | Official Website

In 2023, 11 Biologics companies received 11 FDA inspections in Utah, according to the U.S. Food and Drug Administration (FDA).

This was the second highest number of inspections per type of company made by the FDA in Utah, equalling 12.8% of all inspections in 2023.

Of all the Utah companies involved in the Biologics sector, Utah Cord Bank, LLC, FIOR Bioscience, LLC, and Utah Valley Hospital, tied with one other company, equally received the highest number of 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 Utah During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring62--
Blood and Blood Products72--
Compliance: Devices54--
Food Composition, Standards, Labeling and Econ1092
Foodborne Biological Hazards3111--
Human Cellular, Tissue, and Gene Therapies--2--
Monitoring of Marketed Animal Drugs, Feed, and Devices2----
Postmarket Assurance: Devices71--
Technical Assistance: Food and Cosmetics5----
Vaccines and Allergenic Products3----

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