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Durham Reporter

Tuesday, November 5, 2024

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

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

There were 42 companies in cities associated with Durham County, North Carolina, that received 45 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies inspected in the previous year.

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

There were 30 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (71.4%). 12 should take voluntary action to correct the organization's management operations (28.6%).

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 Durham County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
623 Medical, LLCDevices08/10/2023No Action Indicated (NAI)
Ablexan CorporationDevices01/23/2023No Action Indicated (NAI)
Alcami Carolinas CorporationDrugs03/13/2023Voluntary Action Indicated (VAI)
Allison K. Ross, M.D.Drugs02/16/2023No Action Indicated (NAI)
American Red Cross Blood ServicesBiologics10/16/2023Voluntary Action Indicated (VAI)
AmerisourceBergen Drug CorporationFood/Cosmetics06/15/2023Voluntary Action Indicated (VAI)
Atlantic Fertility Center Partners, LLCBiologics01/11/2023No Action Indicated (NAI)
Avioq, Inc.Biologics12/05/2023Voluntary Action Indicated (VAI)
Bleep, LLCDevices08/25/2023Voluntary Action Indicated (VAI)
Blood Connection, Inc.Biologics06/23/2023No Action Indicated (NAI)
CSL Plasma, Inc.Biologics07/21/2023No Action Indicated (NAI)
Cardinal Health, Inc.Food/Cosmetics09/14/2023No Action Indicated (NAI)
Carolina Conceptions, PABiologics06/01/2023Voluntary Action Indicated (VAI)
Chapel Hill Creamery, LLCFood/Cosmetics11/27/2023No Action Indicated (NAI)
CivaTech Oncology, Inc.Devices06/14/2023Voluntary Action Indicated (VAI)
Clear Choice Therapeutics, Inc.Devices05/11/2023Voluntary Action Indicated (VAI)
Cristina Gasparetto, M.D.Drugs09/29/2023No Action Indicated (NAI)
Deep Blue Medical Advances, Inc.Devices05/18/2023No Action Indicated (NAI)
Durham Exchange Club Industries, Inc.Tobacco02/21/2023No Action Indicated (NAI)
Edward C. Smith, M.D.Drugs03/17/2023No Action Indicated (NAI)
Edwin H. Kim, M.D.Drugs11/08/2023No Action Indicated (NAI)
Epiphany Craft MaltFood/Cosmetics05/16/2023No Action Indicated (NAI)
GlacierPoint Enterprises - CarolinasFood/Cosmetics07/20/2023Voluntary Action Indicated (VAI)
IQVIA BiotechDrugs04/27/2023No Action Indicated (NAI)
Jad Walters, Ph. D.Devices09/06/2023No Action Indicated (NAI)
Ladyfingers Catering, LLCFood/Cosmetics08/09/2023No Action Indicated (NAI)
Lalilab, Inc.Food/Cosmetics03/27/2023No Action Indicated (NAI)
Luminelle, Inc.Devices02/21/2023Voluntary Action Indicated (VAI)
Merz North America, Inc.Devices06/22/2023No Action Indicated (NAI)
North Carolina State University Dairy PlantFood/Cosmetics06/29/2023No Action Indicated (NAI)
Novan, Inc.Drugs06/07/2023No Action Indicated (NAI)
Premier Research and ConsultingDrugs05/17/2023No Action Indicated (NAI)
R & H Produce, Inc.Food/Cosmetics05/17/2023No Action Indicated (NAI)
SpringWorks Therapeutics, Inc.Drugs03/31/2023Voluntary Action Indicated (VAI)
Syneos HealthDrugs02/02/2023No Action Indicated (NAI)
Syneos HealthDrugs07/13/2023No Action Indicated (NAI)
Syneos HealthDrugs08/31/2023No Action Indicated (NAI)
Syneos HealthDrugs12/13/2023No Action Indicated (NAI)
The ICEE CompanyFood/Cosmetics04/04/2023No Action Indicated (NAI)
Thomas L. Ortel, M.D.Biologics07/17/2023No Action Indicated (NAI)
UCB Biosciences, Inc.Drugs03/24/2023No Action Indicated (NAI)
UPS Supply Chain Solutions, Inc.Drugs06/29/2023No Action Indicated (NAI)
Vector Tobacco, LLCTobacco08/09/2023No Action Indicated (NAI)
Wards Fruit & Produce CompanyFood/Cosmetics01/10/2023No Action Indicated (NAI)
restor3d, Inc.Devices05/12/2023Voluntary Action Indicated (VAI)

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