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Sunday, December 22, 2024

FDA Inspection: What type of Colorado companies were under most scrutiny during Q2?

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Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website

In the second quarter of 2024, four Biologics companies received four FDA inspections in Colorado, 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 Colorado, equalling 36.4% of all inspections in the second quarter of 2024.

Of all the Colorado companies involved in the Biologics sector, Albrecht Women's Care received the most citations from the FDA in the second quarter of 2024.

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 Colorado During Q2
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Blood and Blood Products3----
Compliance: Devices11--
Foodborne Biological Hazards31--
Human Cellular, Tissue, and Gene Therapies21--
Monitoring of Marketed Animal Drugs, Feed, and Devices--1--
Technical Assistance: Food and Cosmetics1----

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