East Arapahoe News

There were 23 companies in cities associated with Arapahoe County, Colorado, that received 23 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 14.8% decrease from the number of companies inspected in the previous year, when 27 companies were inspected through 27 inspections.

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

There were 16 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (69.6%). Seven should take voluntary action to correct the organization's management operations (30.4%).

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
Acme Delivery Service, Incorporated	Veterinary	12/21/2023	No Action Indicated (NAI)
Allison Medical, Inc.	Devices	04/28/2023	Voluntary Action Indicated (VAI)
AlloSource	Biologics	03/30/2023	Voluntary Action Indicated (VAI)
CSL Plasma, Inc.	Biologics	04/07/2023	No Action Indicated (NAI)
ClinImmune Labs-University Colorado Cord Blood Bank and Stem Cell Lab	Biologics	09/19/2023	No Action Indicated (NAI)
CoRE labs, LLC	Devices	06/21/2023	Voluntary Action Indicated (VAI)
Colorado Nut Holding Company	Food/Cosmetics	12/06/2023	No Action Indicated (NAI)
D. O. Weaver and Company	Devices	05/12/2023	Voluntary Action Indicated (VAI)
David Fleischer, M.D.	Drugs	01/27/2023	No Action Indicated (NAI)
Dry Bones Denver	Food/Cosmetics	02/13/2023	No Action Indicated (NAI)
Elaine T. Lam, M.D.	Drugs	11/03/2023	No Action Indicated (NAI)
King Soopers Reclamation Center	Food/Cosmetics	04/18/2023	No Action Indicated (NAI)
King Soopers Reclamation Center	Veterinary	04/18/2023	No Action Indicated (NAI)
Lewis, Karl D., M.D.	Biologics	08/07/2023	Voluntary Action Indicated (VAI)
Lucina BioSciences, LLC	Biologics	12/18/2023	No Action Indicated (NAI)
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)
Provital, Inc.	Veterinary	10/04/2023	No Action Indicated (NAI)
Reece, Thomas Brett, M.D.	Devices	12/13/2023	No Action Indicated (NAI)
Share Good Foods, Inc.	Food/Cosmetics	02/23/2023	Voluntary Action Indicated (VAI)
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)