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Saturday, November 23, 2024

Colorado: Device companies were the second least FDA inspected companies in Colorado in Q3 2023

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Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

In the third quarter of 2023, three device companies received three 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 10% of all inspections in the third quarter of 2023.

Of all the Colorado companies involved in the device sector, CD Acquisitions, LLC received the most citations from the FDA in the third 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.

Top 10 FDA Inspections by Number of Actions Indicated in Colorado During Q3 2023
Project AreaNo Action IndicatedVoluntary Action IndicatedOfficial Action Indicated
Bioresearch Monitoring32--
Blood and Blood Products3----
Compliance: Devices11--
Food Composition, Standards, Labeling and Econ--1--
Foodborne Biological Hazards71--
Human Cellular, Tissue, and Gene Therapies3----
Monitoring of Marketed Animal Drugs, Feed, and Devices5----
Postmarket Assurance: Devices1----
Radiation Control and Health Safety Act1----
Technical Assistance: Food and Cosmetics2----

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