FDA conducted inspections of 60 companies in cities located in Wake County in 2024

FDA conducted inspections of 60 companies in cities located in Wake County in 2024
Vid Desai FDA’s Chief Information Officer — Official Website
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There were 60 companies in cities associated with Wake County, North Carolina, that received 62 FDA inspections in 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 20% increase over the number of companies inspected in the previous year, when 50 companies received 54 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 Drugs and Devices sectors.

There were 45 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (75%). 13 should take voluntary action to correct the organization’s management operations (21.7%). Additionally, two companies had to take regulatory and/or administrative actions (3.3%).

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 Wake 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)
American Red Cross Blood Services Biologics 08/13/2024 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)
Biomat USA, Inc. Biologics 10/30/2024 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)
Chiesi USA, Inc. Drugs 08/01/2024 No Action Indicated (NAI)
Choice All Natural D, Inc. Drugs 02/26/2024 Official Action Indicated (OAI)
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)
Dream Vapor Tobacco 06/14/2024 Official Action Indicated (OAI)
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 04/19/2024 Voluntary Action Indicated (VAI)
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)
Kellanova Food and Cosmetics 01/18/2024 No Action Indicated (NAI)
KryoCal, LLC Biologics 06/03/2024 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)
North Carolina Domino’s Pizza Supply Chain Center, LLC Food and Cosmetics 02/13/2024 No Action Indicated (NAI)
Novartis Gene Therapies, Inc. Biologics 01/26/2024 Voluntary Action Indicated (VAI)
OpAns, LLC Drugs 01/24/2024 No Action Indicated (NAI)
PJ Food Service Food and Cosmetics 04/22/2024 No Action Indicated (NAI)
Precision Diabetes, Inc. Devices 03/08/2024 Voluntary Action Indicated (VAI)
Q-Power Incorporated Food and Cosmetics 09/24/2024 Voluntary Action Indicated (VAI)
Revian, Inc. Devices 03/22/2024 Voluntary Action Indicated (VAI)
SGF North Carolina, PLLC Biologics 04/30/2024 No Action Indicated (NAI)
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)
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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