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Thursday, November 7, 2024

How many companies in cities in Arapahoe County received FDA inspections in 2023?

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

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.

Companies Located in Cities Within Arapahoe County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
Acme Delivery Service, IncorporatedVeterinary12/21/2023No Action Indicated (NAI)
Allison Medical, Inc.Devices04/28/2023Voluntary Action Indicated (VAI)
AlloSourceBiologics03/30/2023Voluntary Action Indicated (VAI)
CSL Plasma, Inc.Biologics04/07/2023No Action Indicated (NAI)
ClinImmune Labs-University Colorado Cord Blood Bank and Stem Cell LabBiologics09/19/2023No Action Indicated (NAI)
CoRE labs, LLCDevices06/21/2023Voluntary Action Indicated (VAI)
Colorado Nut Holding CompanyFood/Cosmetics12/06/2023No Action Indicated (NAI)
D. O. Weaver and CompanyDevices05/12/2023Voluntary Action Indicated (VAI)
David Fleischer, M.D.Drugs01/27/2023No Action Indicated (NAI)
Dry Bones DenverFood/Cosmetics02/13/2023No Action Indicated (NAI)
Elaine T. Lam, M.D.Drugs11/03/2023No Action Indicated (NAI)
King Soopers Reclamation CenterFood/Cosmetics04/18/2023No Action Indicated (NAI)
King Soopers Reclamation CenterVeterinary04/18/2023No Action Indicated (NAI)
Lewis, Karl D., M.D.Biologics08/07/2023Voluntary Action Indicated (VAI)
Lucina BioSciences, LLCBiologics12/18/2023No Action Indicated (NAI)
Medical Modeling, a 3D Systems CompanyDevices09/15/2023No Action Indicated (NAI)
Melamed, Isaac R., M.D.Biologics09/01/2023No Action Indicated (NAI)
Paragon 28, Inc.Devices07/13/2023No Action Indicated (NAI)
Provital, Inc.Veterinary10/04/2023No Action Indicated (NAI)
Reece, Thomas Brett, M.D.Devices12/13/2023No Action Indicated (NAI)
Share Good Foods, Inc.Food/Cosmetics02/23/2023Voluntary Action Indicated (VAI)
University of Colorado-Saint Louis Cord Blood BankBiologics09/15/2023No Action Indicated (NAI)
Wright Medical Technology, Inc.Biologics08/09/2023No Action Indicated (NAI)
Yoshicon, LLCTobacco08/10/2023Voluntary Action Indicated (VAI)

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