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 60.5% increase over the number of companies inspected in the previous year, when 38 companies were inspected through 38 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 39 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (63.9%). 20 should take voluntary action to correct the organization's management operations (32.8%). 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.
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.
| 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) |
| Advanced Infusion Solutions | Drugs | 01/30/2023 | Voluntary Action Indicated (VAI) |
| Airport Terminal Services, Inc. | Food/Cosmetics | 05/05/2023 | No Action Indicated (NAI) |
| 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) |
| 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) |
| Buda Juice, LLC | Food/Cosmetics | 11/14/2023 | Voluntary Action Indicated (VAI) |
| Carter BloodCare - Preston Valley | Biologics | 07/07/2023 | No Action Indicated (NAI) |
| Colgin, Inc. | Drugs | 09/21/2023 | Official Action Indicated (OAI) |
| Creative Liquids, LLC | Food/Cosmetics | 07/20/2023 | Voluntary Action Indicated (VAI) |
| DFA Dairy Brands Fluid, LLC | Food/Cosmetics | 01/25/2023 | No Action Indicated (NAI) |
| 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) |
| 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) |
| 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) |
| Galderma Laboratories, L. P. | Devices | 04/05/2023 | No Action Indicated (NAI) |
| Gate Gourmet, Inc. | Food/Cosmetics | 08/08/2023 | No Action Indicated (NAI) |
| Grain Market, LLC | Food/Cosmetics | 07/10/2023 | Voluntary Action Indicated (VAI) |
| Green Valley Food Corporation | Food/Cosmetics | 08/09/2023 | 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) |
| JMD, LLC | Food/Cosmetics | 08/07/2023 | Voluntary Action Indicated (VAI) |
| Julio Rosenstock, M.D. | Drugs | 10/26/2023 | No Action Indicated (NAI) |
| Kavya Foods, Inc. | Food/Cosmetics | 09/22/2023 | Voluntary Action Indicated (VAI) |
| Keurig Dr Pepper | Food/Cosmetics | 11/09/2023 | No Action Indicated (NAI) |
| Marengo Foods Company - Dallas, LLC | Food/Cosmetics | 09/06/2023 | No Action Indicated (NAI) |
| McKinley Resources, Inc. | Food/Cosmetics | 04/04/2023 | No Action Indicated (NAI) |
| McLane Company, Inc. | Food/Cosmetics | 09/07/2023 | 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) |
| 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) |
| Storm Chaser, Corp. | Tobacco | 04/03/2023 | 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) |
| UT Southwestern Medical Center | Biologics | 04/05/2023 | No Action Indicated (NAI) |
| Unifi Aviation, LLC | Food/Cosmetics | 01/25/2023 | Voluntary Action Indicated (VAI) |
| 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) |
| West Pak Avocado | Food/Cosmetics | 10/25/2023 | No Action Indicated (NAI) |
| Yi Group, Inc. | Food/Cosmetics | 09/15/2023 | Voluntary Action Indicated (VAI) |
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