James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 34.1% increase over the number of companies inspected in the previous year, when 88 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 Devices sector.
There were 70 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (59.3%). 44 should take voluntary action to correct the organization's management operations (37.3%). Additionally, four companies had to take regulatory and/or administrative actions (3.4%).
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 Denton 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) |
| Advanced Infusion Solutions | Drugs | 01/30/2023 | Voluntary Action Indicated (VAI) |
| Airport Terminal Services, Inc. | Food/Cosmetics | 05/05/2023 | No Action Indicated (NAI) |
| AldiLLC | Food/Cosmetics | 10/12/2023 | No Action Indicated (NAI) |
| All For Your Cakes, Inc. | Food/Cosmetics | 08/28/2023 | Voluntary Action Indicated (VAI) |
| Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Voluntary Action Indicated (VAI) |
| Americold Logistics | Food/Cosmetics | 07/24/2023 | No Action Indicated (NAI) |
| AmerisourceBergen Drug Corporation | Food/Cosmetics | 08/30/2023 | No Action Indicated (NAI) |
| Ampcare, LLC | Devices | 04/26/2023 | 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) |
| Anbar Distributions, LLC | Food/Cosmetics | 08/17/2023 | Voluntary Action Indicated (VAI) |
| Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Voluntary Action Indicated (VAI) |
| Bankole Osuntokun, M.D. | Drugs | 11/16/2023 | No Action Indicated (NAI) |
| 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) |
| Biscuits & Cookies International | Food/Cosmetics | 08/15/2023 | 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) |
| Carter Bloodcare - Denton | Biologics | 06/15/2023 | 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) |
| 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) |
| Dairy Manufacturers, Inc. | Veterinary | 03/27/2023 | No Action Indicated (NAI) |
| Danone US, LLC. | Food/Cosmetics | 07/14/2023 | No Action Indicated (NAI) |
| Delux Public Charter, LLC | Food/Cosmetics | 09/29/2023 | No Action Indicated (NAI) |
| Dentlight, Inc. | Devices | 08/23/2023 | Voluntary Action Indicated (VAI) |
| 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) |
| Eminent Spine, LLC | Devices | 10/13/2023 | 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) |
| Exel, Inc. | Food/Cosmetics | 08/17/2023 | No Action Indicated (NAI) |
| Farmer Brothers Company | Food/Cosmetics | 06/30/2023 | No Action Indicated (NAI) |
| Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Voluntary Action Indicated (VAI) |
| First Fitness International, Inc. | Food/Cosmetics | 01/25/2023 | Voluntary Action Indicated (VAI) |
| Fruit of the Earth, Inc. | Food/Cosmetics | 10/10/2023 | 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) |
| Green Valley Food Corporation | Food/Cosmetics | 08/09/2023 | No Action Indicated (NAI) |
| H2 Beverages, Inc. | Food/Cosmetics | 02/23/2023 | Voluntary Action Indicated (VAI) |
| Hedonist Biochemical Technologies, Inc. | Devices | 08/08/2023 | 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) |
| John Paul Roberts, FACOG, M.D. | Biologics | 05/05/2023 | No Action Indicated (NAI) |
| Julio Rosenstock, M.D. | Drugs | 10/26/2023 | No Action Indicated (NAI) |
| Kavya Foods, Inc. | Food/Cosmetics | 09/22/2023 | Voluntary Action Indicated (VAI) |
| Kerry, Inc. | Food/Cosmetics | 05/04/2023 | No Action Indicated (NAI) |
| Keurig Dr Pepper | Food/Cosmetics | 11/09/2023 | No Action Indicated (NAI) |
| L. C. Group Ltd., O.D. | Food/Cosmetics | 09/27/2023 | Voluntary Action Indicated (VAI) |
| Lucid Wellness, LLC | Food/Cosmetics | 02/17/2023 | Voluntary Action Indicated (VAI) |
| Mannatech Incorporated | Food/Cosmetics | 09/13/2023 | Voluntary Action Indicated (VAI) |
| Mannatech Incorporated | Food/Cosmetics | 11/09/2023 | 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) |
| Mibo Fresh Foods, LLC | Food/Cosmetics | 01/09/2023 | No Action Indicated (NAI) |
| Michael S. Hisey, M.D. | Devices | 01/30/2023 | No Action Indicated (NAI) |
| Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Voluntary Action Indicated (VAI) |
| Morgan Newton Comp. | Devices | 05/12/2023 | Voluntary Action Indicated (VAI) |
| Mtek Group, LLC | Food/Cosmetics | 09/27/2023 | Voluntary Action Indicated (VAI) |
| Niche Pharmaceuticals, Inc. | Food/Cosmetics | 08/24/2023 | No Action Indicated (NAI) |
| Orthofix U. S., LLC | Devices | 03/17/2023 | Voluntary Action Indicated (VAI) |
| Pacific Rim, LLC | Food/Cosmetics | 07/20/2023 | No Action Indicated (NAI) |
| Parkland Health and Hospital Services System | Biologics | 04/07/2023 | No Action Indicated (NAI) |
| Paul S. Thornton, M.D. | Drugs | 09/15/2023 | 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) |
| Premier Produce Services | Food/Cosmetics | 05/02/2023 | Voluntary Action Indicated (VAI) |
| Prime Supply Distro, LLC | Tobacco | 06/09/2023 | Voluntary Action Indicated (VAI) |
| Pure Gen Holdings, Inc. | Food/Cosmetics | 08/18/2023 | No Action Indicated (NAI) |
| RP Foods, LLC | Food/Cosmetics | 07/06/2023 | Voluntary Action Indicated (VAI) |
| Renfro Foods, Inc. | Food/Cosmetics | 08/31/2023 | Voluntary Action Indicated (VAI) |
| Restaurant Depot | Food/Cosmetics | 01/20/2023 | No Action Indicated (NAI) |
| Saddle Creek Logistic Services | Food/Cosmetics | 10/30/2023 | No Action Indicated (NAI) |
| Saddle Creek Logistics Services | Food/Cosmetics | 07/06/2023 | No Action Indicated (NAI) |
| Select Corporation | Drugs | 09/14/2023 | Voluntary Action Indicated (VAI) |
| Selery Fulfillment, Inc. | Food/Cosmetics | 04/12/2023 | Voluntary Action Indicated (VAI) |
| Signature Flight Support | Food/Cosmetics | 05/16/2023 | No Action Indicated (NAI) |
| Somnomed, Inc. | Devices | 03/16/2023 | 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) |
| Sovereign Pharmaceuticals, LLC | Drugs | 08/02/2023 | Official Action Indicated (OAI) |
| St. Charles Trading, Inc. | Food/Cosmetics | 08/14/2023 | No Action Indicated (NAI) |
| Steri-Tek, LLC | Devices | 09/26/2023 | Voluntary Action Indicated (VAI) |
| Sterigenics US, LLC | Devices | 08/17/2023 | 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) |
| 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) |
| The Morrison Milling Company | Food/Cosmetics | 10/25/2023 | No Action Indicated (NAI) |
| The Sygma Network | Food/Cosmetics | 01/19/2023 | No Action Indicated (NAI) |
| Third Coast Marketing Holdings, LP | Food/Cosmetics | 08/03/2023 | Voluntary Action Indicated (VAI) |
| Timothy E. Ritter, M.D. | Drugs | 03/30/2023 | No Action Indicated (NAI) |
| 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) |
| West Pak Avocado | Food/Cosmetics | 10/25/2023 | No Action Indicated (NAI) |
| WildMillet, LLC | Food/Cosmetics | 04/10/2023 | No Action Indicated (NAI) |
| Yi Group, Inc. | Food/Cosmetics | 09/15/2023 | Voluntary Action Indicated (VAI) |
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