West Arapahoe News

There were eight companies in cities associated with Arapahoe County, Colorado, that received eight FDA inspections in the third quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 60% increase over the number of companies inspected in the previous quarter, when five companies received five inspections.

Most of the companies inspected at the time were involved in the Biologics sector. The second most common type of company inspected worked in the Devices sector.

There were six companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions. Two should take voluntary action to correct their management operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Result
ClinImmune Labs-University Colorado Cord Blood Bank and Stem Cell Lab	Biologics	09/19/2023	No Action Indicated (NAI)
Lewis, Karl D., M.D.	Biologics	08/07/2023	Voluntary Action Indicated (VAI)
Medical Modeling, a 3D Systems Company	Devices	09/15/2023	No Action Indicated (NAI)
Melamed, Isaac R., M.D.	Biologics	09/01/2023	No Action Indicated (NAI)
Paragon 28, Inc.	Devices	07/13/2023	No Action Indicated (NAI)
University of Colorado-Saint Louis Cord Blood Bank	Biologics	09/15/2023	No Action Indicated (NAI)
Wright Medical Technology, Inc.	Biologics	08/09/2023	No Action Indicated (NAI)
Yoshicon, LLC	Tobacco	08/10/2023	Voluntary Action Indicated (VAI)