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.
| 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) |



