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Friday, May 3, 2024

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

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

In 2023, 11 Biologics companies received 11 FDA inspections in Montana, 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 Montana, equalling 20.8% of all inspections in 2023.

Of all the Montana companies involved in the Biologics sector, Billings Clinic Innovative Fertility 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.

FDA Inspections in Montana During 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products10----
Colors and Cosmetics Technology2----
Food Composition, Standards, Labeling and Econ--4--
Foodborne Biological Hazards182--
Human Cellular, Tissue, and Gene Therapies11--
Monitoring of Marketed Animal Drugs, Feed, and Devices8----
Technical Assistance: Food and Cosmetics101--
Tobacco Post-Market Activities1----

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