Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 23.1% increase over the number of companies inspected in the previous year, when 91 companies were inspected through 93 inspections.
Most of the companies inspected were involved in the Food/Cosmetics sector. The second most common type of company inspected in the time period worked in the Biologics sector.
There were 62 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (55.4%). 46 should take voluntary action to correct the organization's management operations (41.1%). Additionally, five companies had to take regulatory and/or administrative actions (4.5%).
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 Dallas County and Their Inspection Results
| Company Name | Area of Business | Inspection Date | Result |
|---|---|---|---|
| 1910 Distribution Company, LLC | Food/Cosmetics | 10/25/2023 | No Action Indicated (NAI) |
| 4 Aces Import, Inc. | Food/Cosmetics | 02/10/2023 | No Action Indicated (NAI) |
| ARG Laboratories, Inc. | Drugs | 09/20/2023 | Official Action Indicated (OAI) |
| Action Imports LP | Food/Cosmetics | 01/19/2023 | No Action Indicated (NAI) |
| Ada Teff | Food/Cosmetics | 05/29/2023 | No Action Indicated (NAI) |
| Advanced Infusion Solutions | Drugs | 01/30/2023 | Voluntary Action Indicated (VAI) |
| AdvoCare International, LLC | Food/Cosmetics | 01/20/2023 | No Action Indicated (NAI) |
| Airport Terminal Services, Inc. | Food/Cosmetics | 05/05/2023 | No Action Indicated (NAI) |
| All For Your Cakes, Inc. | Food/Cosmetics | 08/28/2023 | Voluntary Action Indicated (VAI) |
| America's Beverage Company | Food/Cosmetics | 04/19/2023 | No Action Indicated (NAI) |
| American Chinese Natural Herbs, Inc. | Food/Cosmetics | 08/14/2023 | Voluntary Action Indicated (VAI) |
| Amware Fulfillment, LLC | Food/Cosmetics | 12/05/2023 | No Action Indicated (NAI) |
| Amware Fulfillment, LLC | Drugs | 05/31/2023 | No Action Indicated (NAI) |
| Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Voluntary Action Indicated (VAI) |
| Aspire Fertility Institute Dallas | Biologics | 07/12/2023 | Voluntary Action Indicated (VAI) |
| Baylor Institute For Immunology | Biologics | 03/01/2023 | No Action Indicated (NAI) |
| Baylor University Medical Center Transfusion Services | Biologics | 06/13/2023 | No Action Indicated (NAI) |
| Beverage King, LLC | Food/Cosmetics | 07/13/2023 | Voluntary Action Indicated (VAI) |
| BioLife Plasma Services L. P. | Biologics | 03/23/2023 | No Action Indicated (NAI) |
| Buda Juice, LLC | Food/Cosmetics | 11/14/2023 | Voluntary Action Indicated (VAI) |
| Carrollclean, LLC | Drugs | 08/31/2023 | Voluntary Action Indicated (VAI) |
| Carter BloodCare - Preston Valley | Biologics | 07/07/2023 | No Action Indicated (NAI) |
| Carter BloodCare Irving, TX Donor Center | Biologics | 02/09/2023 | No Action Indicated (NAI) |
| Carter BloodCare at Garland | Biologics | 08/15/2023 | No Action Indicated (NAI) |
| Colgin, Inc. | Drugs | 09/21/2023 | Official Action Indicated (OAI) |
| Cosmax Nbt Usa, Inc. | Food/Cosmetics | 10/20/2023 | No Action Indicated (NAI) |
| Creative Liquids, LLC | Food/Cosmetics | 07/20/2023 | Voluntary Action Indicated (VAI) |
| Cygnus Home Service, LLC | Food/Cosmetics | 09/06/2023 | No Action Indicated (NAI) |
| DFA Dairy Brands Fluid, LLC | Food/Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
| Dart Container Corporation | Food/Cosmetics | 08/25/2023 | Voluntary Action Indicated (VAI) |
| Delux Public Charter, LLC | Food/Cosmetics | 09/29/2023 | No Action Indicated (NAI) |
| Dhaliwal Laboratories, LLC | Veterinary | 02/07/2023 | Voluntary Action Indicated (VAI) |
| Distribution Management, Inc. | Food/Cosmetics | 12/18/2023 | No Action Indicated (NAI) |
| Divine Design Manufacturing | Food/Cosmetics | 11/21/2023 | Voluntary Action Indicated (VAI) |
| Dude, Sweet Chocolate, LLC | Food/Cosmetics | 08/25/2023 | No Action Indicated (NAI) |
| Eagles Eight Eleven, LLC | Food/Cosmetics | 10/24/2023 | No Action Indicated (NAI) |
| El Gordo Spices, LLC | Food/Cosmetics | 03/22/2023 | Voluntary Action Indicated (VAI) |
| Envirotein, LLC | Veterinary | 05/10/2023 | No Action Indicated (NAI) |
| Envoy | Food/Cosmetics | 05/31/2023 | No Action Indicated (NAI) |
| Essendant Company | Food/Cosmetics | 02/22/2023 | No Action Indicated (NAI) |
| Essendant Company | Food/Cosmetics | 05/10/2023 | No Action Indicated (NAI) |
| Ethen Foods USA, Inc. | Food/Cosmetics | 02/06/2023 | No Action Indicated (NAI) |
| Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Voluntary Action Indicated (VAI) |
| Fruge Distribution, Inc. | Food/Cosmetics | 07/19/2023 | No Action Indicated (NAI) |
| Fruit Of The Earth Research Laboratories, Inc. | Drugs | 03/31/2023 | Voluntary Action Indicated (VAI) |
| Fruit Of The Earth Research Laboratories, Inc. | Food/Cosmetics | 04/14/2023 | No Action Indicated (NAI) |
| Galderma Laboratories, L. P. | Devices | 04/05/2023 | No Action Indicated (NAI) |
| Gate Gourmet, Inc. | Food/Cosmetics | 08/08/2023 | No Action Indicated (NAI) |
| Genesis Biosystems, Inc. | Devices | 01/09/2023 | Voluntary Action Indicated (VAI) |
| Grain Market, LLC | Food/Cosmetics | 07/10/2023 | Voluntary Action Indicated (VAI) |
| Great Western Malting Company | Food/Cosmetics | 11/06/2023 | No Action Indicated (NAI) |
| Green Valley Food Corporation | Food/Cosmetics | 08/09/2023 | No Action Indicated (NAI) |
| Gruma Corporation | Food/Cosmetics | 08/30/2023 | No Action Indicated (NAI) |
| Hiland Dairy Foods Company, LLC | Food/Cosmetics | 08/04/2023 | Voluntary Action Indicated (VAI) |
| Hines Nut Company | Food/Cosmetics | 10/31/2023 | No Action Indicated (NAI) |
| IVF Institute, P. A. | Biologics | 12/11/2023 | No Action Indicated (NAI) |
| InReach Convenient Solutions | Food/Cosmetics | 03/06/2023 | Voluntary Action Indicated (VAI) |
| JMD, LLC | Food/Cosmetics | 08/07/2023 | Voluntary Action Indicated (VAI) |
| Julio Rosenstock, M.D. | Drugs | 10/26/2023 | No Action Indicated (NAI) |
| Kaurina's, LLC | Food/Cosmetics | 06/29/2023 | No Action Indicated (NAI) |
| Kavya Foods, Inc. | Food/Cosmetics | 09/22/2023 | Voluntary Action Indicated (VAI) |
| Kedplasma, LLC | Biologics | 07/12/2023 | No Action Indicated (NAI) |
| Keurig Dr Pepper | Food/Cosmetics | 11/09/2023 | No Action Indicated (NAI) |
| Kevala International, LLC | Food/Cosmetics | 01/17/2023 | Voluntary Action Indicated (VAI) |
| Komplete Group, Inc. | Food/Cosmetics | 10/23/2023 | No Action Indicated (NAI) |
| Korean Food, Inc. | Food/Cosmetics | 08/25/2023 | Official Action Indicated (OAI) |
| Korean Food, Inc. | Food/Cosmetics | 08/25/2023 | Voluntary Action Indicated (VAI) |
| La Fabrica, LLC | Food/Cosmetics | 11/06/2023 | Voluntary Action Indicated (VAI) |
| LinkEx, Inc. | Food/Cosmetics | 01/09/2023 | No Action Indicated (NAI) |
| Marengo Foods Company - Dallas, LLC | Food/Cosmetics | 09/06/2023 | No Action Indicated (NAI) |
| Marriott International, Inc. | Food/Cosmetics | 11/13/2023 | Voluntary Action Indicated (VAI) |
| Mary Kay, Inc. | Drugs | 10/27/2023 | Voluntary Action Indicated (VAI) |
| McKinley Resources, Inc. | Food/Cosmetics | 04/04/2023 | No Action Indicated (NAI) |
| McLane Company, Inc. | Food/Cosmetics | 09/07/2023 | No Action Indicated (NAI) |
| Melinda's Foods, LLC | Food/Cosmetics | 01/12/2023 | Voluntary Action Indicated (VAI) |
| Mission Produce, Inc. | Food/Cosmetics | 06/06/2023 | Voluntary Action Indicated (VAI) |
| National Entertainment Network | Food/Cosmetics | 09/14/2023 | No Action Indicated (NAI) |
| Neos Therapeutics, LP | Drugs | 08/25/2023 | Voluntary Action Indicated (VAI) |
| Orthofix U. S., LLC | Devices | 03/17/2023 | Voluntary Action Indicated (VAI) |
| Osteomed, LLC | Devices | 08/28/2023 | No Action Indicated (NAI) |
| Parkland Health and Hospital Services System | Biologics | 04/07/2023 | No Action Indicated (NAI) |
| Performance Food Group, Inc. | Food/Cosmetics | 01/10/2023 | No Action Indicated (NAI) |
| Post Oak Innovations, Inc. | Devices | 10/13/2023 | Voluntary Action Indicated (VAI) |
| Prime Supply Distro, LLC | Tobacco | 06/09/2023 | Voluntary Action Indicated (VAI) |
| RP Foods, LLC | Food/Cosmetics | 07/06/2023 | Voluntary Action Indicated (VAI) |
| Restaurant Depot | Food/Cosmetics | 01/20/2023 | No Action Indicated (NAI) |
| Rockit Imports | Food/Cosmetics | 07/12/2023 | No Action Indicated (NAI) |
| Scott R. Bartley, M.D. | Drugs | 02/17/2023 | Voluntary Action Indicated (VAI) |
| Select Corporation | Drugs | 09/14/2023 | Voluntary Action Indicated (VAI) |
| Selery Fulfillment, Inc. | Food/Cosmetics | 04/12/2023 | Voluntary Action Indicated (VAI) |
| Shippers Warehouse, Inc. | Food/Cosmetics | 06/09/2023 | No Action Indicated (NAI) |
| Signature Flight Support | Food/Cosmetics | 05/16/2023 | No Action Indicated (NAI) |
| SouQ El Sudan, Inc. | Food/Cosmetics | 09/08/2023 | Voluntary Action Indicated (VAI) |
| Southwest Airlines | Food/Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
| Southwest Transplant Alliance, Inc. | Biologics | 02/03/2023 | No Action Indicated (NAI) |
| St. Charles Trading, Inc. | Food/Cosmetics | 08/14/2023 | No Action Indicated (NAI) |
| Steri-Tek, LLC | Devices | 09/26/2023 | Voluntary Action Indicated (VAI) |
| Storm Chaser, Corp. | Tobacco | 04/03/2023 | Voluntary Action Indicated (VAI) |
| Taka USA, Inc. | Drugs | 02/07/2023 | Official Action Indicated (OAI) |
| Talia Foods, LLC | Food/Cosmetics | 09/15/2023 | Voluntary Action Indicated (VAI) |
| Taylor Farms Texas | Food/Cosmetics | 09/06/2023 | No Action Indicated (NAI) |
| Taylor Farms Texas, Inc. | Food/Cosmetics | 09/12/2023 | No Action Indicated (NAI) |
| Third Coast Marketing Holdings, LP | Food/Cosmetics | 08/03/2023 | Voluntary Action Indicated (VAI) |
| Thomsons Importers & Exporters | Food/Cosmetics | 04/14/2023 | Voluntary Action Indicated (VAI) |
| Tiger Sugar DFW, LLC | Food/Cosmetics | 06/27/2023 | Voluntary Action Indicated (VAI) |
| UT Southwestern Medical Center | Biologics | 04/05/2023 | No Action Indicated (NAI) |
| Unifi Aviation, LLC | Food/Cosmetics | 01/25/2023 | Voluntary Action Indicated (VAI) |
| United Laboratories Manufacturing, LLC | Food/Cosmetics | 05/09/2023 | No Action Indicated (NAI) |
| University of Texas Southwestern Medical Center, The | Devices | 02/09/2023 | No Action Indicated (NAI) |
| VA - North Texas Health Care System | Biologics | 04/10/2023 | No Action Indicated (NAI) |
| Value Feeds, LLC | Veterinary | 07/06/2023 | No Action Indicated (NAI) |
| Wello, Inc. | Devices | 06/21/2023 | Official Action Indicated (OAI) |
| West Pak Avocado | Food/Cosmetics | 10/25/2023 | No Action Indicated (NAI) |
| Xochitl Gourmet Foods, LLC | Food/Cosmetics | 01/25/2023 | Voluntary Action Indicated (VAI) |
| Yi Group, Inc. | Food/Cosmetics | 09/15/2023 | Voluntary Action Indicated (VAI) |
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