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Tuesday, November 5, 2024

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

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

There were 37 companies in cities associated with Mecklenburg County, North Carolina, that received 38 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 23.3% increase over the number of companies inspected in the previous year, when 30 companies were inspected through 30 inspections.

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

There were 28 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (75.7%). Eight should take voluntary action to correct the organization's management operations (21.6%). Additionally, one company had to take regulatory and/or administrative actions (2.7%).

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 Mecklenburg County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
Almased USA, Inc.Food/Cosmetics11/06/2023No Action Indicated (NAI)
American National Red Cross Carolinas RegionBiologics02/01/2023No Action Indicated (NAI)
American Red CrossBiologics02/08/2023No Action Indicated (NAI)
American Red Cross Blood Services Carolinas RegionBiologics05/03/2023No Action Indicated (NAI)
American Sprinkle CompanyFood/Cosmetics02/15/2023No Action Indicated (NAI)
Bakkavor Foods USA, Inc.Food/Cosmetics02/24/2023Official Action Indicated (OAI)
Bakkavor Foods USA, Inc.Food/Cosmetics12/01/2023No Action Indicated (NAI)
Barnett International CorporationDevices08/08/2023No Action Indicated (NAI)
Beat Childhood Cancer, Levine Childrens HospitalDrugs02/06/2023No Action Indicated (NAI)
BioLife Plasma ServicesBiologics08/17/2023No Action Indicated (NAI)
Birth Tissue Recovery, LLCBiologics05/09/2023No Action Indicated (NAI)
CSL Plasma, Inc.Biologics05/25/2023No Action Indicated (NAI)
Canteen CharlotteFood/Cosmetics05/04/2023No Action Indicated (NAI)
Charlotte Mecklenburg Hospital AuthorityBiologics05/18/2023Voluntary Action Indicated (VAI)
DEXIOS Services, LLCDevices07/21/2023No Action Indicated (NAI)
Distribution Technology, Inc.Food/Cosmetics03/09/2023No Action Indicated (NAI)
Emage Medical, LLCDevices04/04/2023Voluntary Action Indicated (VAI)
GlobalMed Logistix, LLCBiologics10/26/2023No Action Indicated (NAI)
Life Sensing Instruments, Inc.Devices01/27/2023Voluntary Action Indicated (VAI)
Mad Barn USA, Inc.Food/Cosmetics01/24/2023No Action Indicated (NAI)
Madrona Specialty Foods, LLCFood/Cosmetics12/06/2023No Action Indicated (NAI)
Martin's Distribution, Inc.Food/Cosmetics03/08/2023No Action Indicated (NAI)
Mohammad R. Bolouri, M.D.Drugs04/04/2023No Action Indicated (NAI)
NoDa Brewing CompanyFood/Cosmetics06/28/2023No Action Indicated (NAI)
NoDa Brewing CompanyVeterinary06/28/2023No Action Indicated (NAI)
Octapharma Plasma, Inc.Biologics07/21/2023No Action Indicated (NAI)
OneBlood, Inc.Biologics10/26/2023No Action Indicated (NAI)
Orange Bakery, Inc.Food/Cosmetics05/18/2023Voluntary Action Indicated (VAI)
Pennys Gourmet Foods, LLCFood/Cosmetics01/09/2023No Action Indicated (NAI)
REACT InnovationsDevices02/17/2023Voluntary Action Indicated (VAI)
Reproductive Endocrinology Associates of CharlotteBiologics05/11/2023No Action Indicated (NAI)
Reproductive Specialists of the CarolinasBiologics05/04/2023No Action Indicated (NAI)
Salvin Dental Specialties, Inc.Biologics10/27/2023No Action Indicated (NAI)
Shebli Atrash, M.D.Drugs03/16/2023No Action Indicated (NAI)
Sol International, LLCFood/Cosmetics11/08/2023Voluntary Action Indicated (VAI)
Summit Coffee Roasting Company, LLC.Food/Cosmetics01/10/2023No Action Indicated (NAI)
The Program for Assisted Reproduction at Atrium Health's Carolinas Medical CenterBiologics05/10/2023No Action Indicated (NAI)
USA Facemask, LLCDevices03/17/2023Voluntary Action Indicated (VAI)
Van Harvest Distribution, LLC.Food/Cosmetics03/30/2023Voluntary Action Indicated (VAI)

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