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Wednesday, November 6, 2024

Colorado: Biologics companies were the second least FDA inspected companies in Colorado in Q2 2023

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

In the second quarter of 2023, four Biologics companies received four FDA inspections in Colorado, according to the U.S. Food and Drug Administration (FDA).

This was the second lowest number of inspections per type of company made by the FDA in Colorado, equalling 9.5% of all inspections in the second quarter of 2023.

Of all the Colorado companies involved in the Biologics sector, Biolife Plasma Services L. P. received the most citations from the FDA in the second 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 Colorado During Q2 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring51--
Blood and Blood Products31--
Compliance: Devices--4--
Foodborne Biological Hazards154--
Monitoring of Marketed Animal Drugs, Feed, and Devices71--
Postmarket Assurance: Devices21--
Technical Assistance: Food and Cosmetics3----
Vaccines and Allergenic Products1----

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