Durham County cities: 51 companies received FDA inspections in 2024

Durham County cities: 51 companies received FDA inspections in 2024
Mark Raza Principal Deputy Chief Counsel - FDA — Official Website
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There were 51 companies in cities associated with Durham County, North Carolina, that received 53 FDA inspections in 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 10.9% increase over the number of companies inspected in the previous year, when 46 companies received 50 inspections.

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

There were 40 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (78.4%). 11 should take voluntary action to correct the organization’s management operations (21.6%).

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.

According to its website, 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.

Companies Located in Cities Within Durham County and Their Inspection Results
Company Name Area of Business Inspection Date Result
410 Medical, Inc. Devices 08/16/2024 No Action Indicated (NAI)
American Red Cross Biologics 03/18/2024 No Action Indicated (NAI)
Amtai Medical Equipment, Inc. Devices 12/06/2024 Voluntary Action Indicated (VAI)
Andersen Scientific, Inc. Devices 06/06/2024 No Action Indicated (NAI)
Annick Desjardins, M.D. Biologics 05/08/2024 No Action Indicated (NAI)
Bioaesthetics Corporation Biologics 10/03/2024 No Action Indicated (NAI)
Biomat USA, Inc. Biologics 10/24/2024 No Action Indicated (NAI)
Bioresource International, Inc. Veterinary 07/26/2024 No Action Indicated (NAI)
Birth Tissue Recovery Biologics 06/17/2024 No Action Indicated (NAI)
Blood Connection, Inc. Biologics 05/02/2024 No Action Indicated (NAI)
California Cryobank, LLC Biologics 09/13/2024 No Action Indicated (NAI)
Carolinas Cord Blood Bank Biologics 09/27/2024 No Action Indicated (NAI)
Carolinas Cord Blood Bank Biologics 11/22/2024 No Action Indicated (NAI)
Catalent Pharma Solutions, LLC Biologics 05/24/2024 Voluntary Action Indicated (VAI)
Christopher J. Sayed, M.D. Drugs 07/15/2024 No Action Indicated (NAI)
Contego Medical, LLC Devices 08/21/2024 No Action Indicated (NAI)
Cryos International USA, LLC Biologics 03/22/2024 Voluntary Action Indicated (VAI)
David S Huber Pipes Tobacco 05/30/2024 No Action Indicated (NAI)
Digisonics, Inc. Devices 08/12/2024 No Action Indicated (NAI)
Duke Fertility Center Biologics 04/04/2024 No Action Indicated (NAI)
Duke University Medical Center Duke Hospital North Biologics 05/09/2024 No Action Indicated (NAI)
Emad M. Hasan, M.D. Drugs 04/04/2024 No Action Indicated (NAI)
GlaxoSmithKline, LLC Drugs 08/16/2024 No Action Indicated (NAI)
Humacyte Global, Inc. Biologics 06/17/2024 No Action Indicated (NAI)
Indivior Manufacturing, LLC Biologics 01/18/2024 Voluntary Action Indicated (VAI)
Indivior Manufacturing, LLC Drugs 07/26/2024 Voluntary Action Indicated (VAI)
Jad Walters, Ph. D. Devices 11/07/2024 No Action Indicated (NAI)
James P. Zidar, M.D. Devices 08/07/2024 No Action Indicated (NAI)
Katherine Peters, M.D. Drugs 03/21/2024 No Action Indicated (NAI)
Lalilab, Inc. Food and Cosmetics 05/15/2024 No Action Indicated (NAI)
Mark Delegge, M.D. Devices 08/09/2024 No Action Indicated (NAI)
Matthew R. Kappus, M.D. Drugs 01/11/2024 No Action Indicated (NAI)
Matthew S. McKinney, M.D. Biologics 09/11/2024 No Action Indicated (NAI)
Merck Sharp & Dohme, LLC Biologics 06/12/2024 No Action Indicated (NAI)
Mp Pharma Services, Inc. Drugs 08/30/2024 No Action Indicated (NAI)
Neomonde Baking Company Food and Cosmetics 08/16/2024 Voluntary Action Indicated (VAI)
Novartis Gene Therapies, Inc. Biologics 01/26/2024 Voluntary Action Indicated (VAI)
OpAns, LLC Drugs 01/24/2024 No Action Indicated (NAI)
Precision Diabetes, Inc. Devices 03/08/2024 Voluntary Action Indicated (VAI)
Revian, Inc. Devices 03/22/2024 Voluntary Action Indicated (VAI)
Signature Flight Support [RDU] Food and Cosmetics 02/27/2024 No Action Indicated (NAI)
Suntech Medical, Inc. Devices 05/22/2024 Voluntary Action Indicated (VAI)
Syneos Health Drugs 04/19/2024 No Action Indicated (NAI)
Tergus Pharma, LLC Drugs 12/13/2024 No Action Indicated (NAI)
Transfusion Medicine Service UNC Hospitals Biologics 05/24/2024 No Action Indicated (NAI)
UNC Chapel Hill Office of Human Research Ethics Drugs 03/15/2024 No Action Indicated (NAI)
UNC Health Rex Biologics 09/09/2024 No Action Indicated (NAI)
UNC Healthcare/Fertility Biologics 03/19/2024 No Action Indicated (NAI)
United Airlines Food and Cosmetics 03/12/2024 No Action Indicated (NAI)
VA Medical Center IRB Devices 12/10/2024 No Action Indicated (NAI)
VA Medical Center IRB Drugs 12/10/2024 No Action Indicated (NAI)
Veterans Administration Medical Center Laboratory Service Biologics 03/20/2024 No Action Indicated (NAI)
WakeMed IRB Devices 04/29/2024 Voluntary Action Indicated (VAI)
WakeMed IRB Drugs 04/29/2024 Voluntary Action Indicated (VAI)
WakeMed IRB Biologics 04/29/2024 No Action Indicated (NAI)
restor3d, Inc. Devices 06/14/2024 Voluntary Action Indicated (VAI)


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