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Tuesday, November 5, 2024

Denton County cities: 118 companies received FDA inspections in 2023

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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

There were 118 companies in cities associated with Denton County, Texas, that received 119 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

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 NameArea of BusinessInspection DateResult
1910 Distribution Company, LLCFood/Cosmetics10/25/2023No Action Indicated (NAI)
4 Aces Import, Inc.Food/Cosmetics02/10/2023No Action Indicated (NAI)
ARG Laboratories, Inc.Drugs09/20/2023Official Action Indicated (OAI)
Advanced Infusion SolutionsDrugs01/30/2023Voluntary Action Indicated (VAI)
Airport Terminal Services, Inc.Food/Cosmetics05/05/2023No Action Indicated (NAI)
AldiLLCFood/Cosmetics10/12/2023No Action Indicated (NAI)
All For Your Cakes, Inc.Food/Cosmetics08/28/2023Voluntary Action Indicated (VAI)
Amcor Rigid Packaging USA, LLCDevices01/12/2023Voluntary Action Indicated (VAI)
Americold LogisticsFood/Cosmetics07/24/2023No Action Indicated (NAI)
AmerisourceBergen Drug CorporationFood/Cosmetics08/30/2023No Action Indicated (NAI)
Ampcare, LLCDevices04/26/2023No Action Indicated (NAI)
Amware Fulfillment, LLCFood/Cosmetics12/05/2023No Action Indicated (NAI)
Amware Fulfillment, LLCDrugs05/31/2023No Action Indicated (NAI)
Anbar Distributions, LLCFood/Cosmetics08/17/2023Voluntary Action Indicated (VAI)
Anesthetic Gas Reclamation, Inc.Devices05/04/2023Voluntary Action Indicated (VAI)
Bankole Osuntokun, M.D.Drugs11/16/2023No Action Indicated (NAI)
Baylor Institute For ImmunologyBiologics03/01/2023No Action Indicated (NAI)
Baylor University Medical Center Transfusion ServicesBiologics06/13/2023No Action Indicated (NAI)
Beverage King, LLCFood/Cosmetics07/13/2023Voluntary Action Indicated (VAI)
BioLife Plasma Services L. P.Biologics03/23/2023No Action Indicated (NAI)
Biscuits & Cookies InternationalFood/Cosmetics08/15/2023Voluntary Action Indicated (VAI)
Buda Juice, LLCFood/Cosmetics11/14/2023Voluntary Action Indicated (VAI)
Carter BloodCare - Preston ValleyBiologics07/07/2023No Action Indicated (NAI)
Carter Bloodcare - DentonBiologics06/15/2023No Action Indicated (NAI)
Colgin, Inc.Drugs09/21/2023Official Action Indicated (OAI)
Creative Liquids, LLCFood/Cosmetics07/20/2023Voluntary Action Indicated (VAI)
Cygnus Home Service, LLCFood/Cosmetics09/06/2023No Action Indicated (NAI)
DFA Dairy Brands Fluid, LLCFood/Cosmetics01/25/2023No Action Indicated (NAI)
Dairy Manufacturers, Inc.Veterinary03/27/2023No Action Indicated (NAI)
Danone US, LLC.Food/Cosmetics07/14/2023No Action Indicated (NAI)
Delux Public Charter, LLCFood/Cosmetics09/29/2023No Action Indicated (NAI)
Dentlight, Inc.Devices08/23/2023Voluntary Action Indicated (VAI)
Dhaliwal Laboratories, LLCVeterinary02/07/2023Voluntary Action Indicated (VAI)
Distribution Management, Inc.Food/Cosmetics12/18/2023No Action Indicated (NAI)
Dude, Sweet Chocolate, LLCFood/Cosmetics08/25/2023No Action Indicated (NAI)
Eagles Eight Eleven, LLCFood/Cosmetics10/24/2023No Action Indicated (NAI)
El Gordo Spices, LLCFood/Cosmetics03/22/2023Voluntary Action Indicated (VAI)
Eminent Spine, LLCDevices10/13/2023Voluntary Action Indicated (VAI)
Envirotein, LLCVeterinary05/10/2023No Action Indicated (NAI)
EnvoyFood/Cosmetics05/31/2023No Action Indicated (NAI)
Ethen Foods USA, Inc.Food/Cosmetics02/06/2023No Action Indicated (NAI)
Exel, Inc.Food/Cosmetics08/17/2023No Action Indicated (NAI)
Farmer Brothers CompanyFood/Cosmetics06/30/2023No Action Indicated (NAI)
Fertility and Advanced Reproductive Medicine at UTSWBiologics12/13/2023Voluntary Action Indicated (VAI)
First Fitness International, Inc.Food/Cosmetics01/25/2023Voluntary Action Indicated (VAI)
Fruit of the Earth, Inc.Food/Cosmetics10/10/2023No Action Indicated (NAI)
Galderma Laboratories, L. P.Devices04/05/2023No Action Indicated (NAI)
Gate Gourmet, Inc.Food/Cosmetics08/08/2023No Action Indicated (NAI)
Genesis Biosystems, Inc.Devices01/09/2023Voluntary Action Indicated (VAI)
Grain Market, LLCFood/Cosmetics07/10/2023Voluntary Action Indicated (VAI)
Green Valley Food CorporationFood/Cosmetics08/09/2023No Action Indicated (NAI)
H2 Beverages, Inc.Food/Cosmetics02/23/2023Voluntary Action Indicated (VAI)
Hedonist Biochemical Technologies, Inc.Devices08/08/2023No Action Indicated (NAI)
Hiland Dairy Foods Company, LLCFood/Cosmetics08/04/2023Voluntary Action Indicated (VAI)
Hines Nut CompanyFood/Cosmetics10/31/2023No Action Indicated (NAI)
IVF Institute, P. A.Biologics12/11/2023No Action Indicated (NAI)
JMD, LLCFood/Cosmetics08/07/2023Voluntary Action Indicated (VAI)
John Paul Roberts, FACOG, M.D.Biologics05/05/2023No Action Indicated (NAI)
Julio Rosenstock, M.D.Drugs10/26/2023No Action Indicated (NAI)
Kavya Foods, Inc.Food/Cosmetics09/22/2023Voluntary Action Indicated (VAI)
Kerry, Inc.Food/Cosmetics05/04/2023No Action Indicated (NAI)
Keurig Dr PepperFood/Cosmetics11/09/2023No Action Indicated (NAI)
L. C. Group Ltd., O.D.Food/Cosmetics09/27/2023Voluntary Action Indicated (VAI)
Lucid Wellness, LLCFood/Cosmetics02/17/2023Voluntary Action Indicated (VAI)
Mannatech IncorporatedFood/Cosmetics09/13/2023Voluntary Action Indicated (VAI)
Mannatech IncorporatedFood/Cosmetics11/09/2023No Action Indicated (NAI)
Marengo Foods Company - Dallas, LLCFood/Cosmetics09/06/2023No Action Indicated (NAI)
Marriott International, Inc.Food/Cosmetics11/13/2023Voluntary Action Indicated (VAI)
Mary Kay, Inc.Drugs10/27/2023Voluntary Action Indicated (VAI)
McKinley Resources, Inc.Food/Cosmetics04/04/2023No Action Indicated (NAI)
McLane Company, Inc.Food/Cosmetics09/07/2023No Action Indicated (NAI)
Mibo Fresh Foods, LLCFood/Cosmetics01/09/2023No Action Indicated (NAI)
Michael S. Hisey, M.D.Devices01/30/2023No Action Indicated (NAI)
Mid-States Distributing, LLCVeterinary09/11/2023Voluntary Action Indicated (VAI)
Morgan Newton Comp.Devices05/12/2023Voluntary Action Indicated (VAI)
Mtek Group, LLCFood/Cosmetics09/27/2023Voluntary Action Indicated (VAI)
Niche Pharmaceuticals, Inc.Food/Cosmetics08/24/2023No Action Indicated (NAI)
Orthofix U. S., LLCDevices03/17/2023Voluntary Action Indicated (VAI)
Pacific Rim, LLCFood/Cosmetics07/20/2023No Action Indicated (NAI)
Parkland Health and Hospital Services SystemBiologics04/07/2023No Action Indicated (NAI)
Paul S. Thornton, M.D.Drugs09/15/2023No Action Indicated (NAI)
Performance Food Group, Inc.Food/Cosmetics01/10/2023No Action Indicated (NAI)
Post Oak Innovations, Inc.Devices10/13/2023Voluntary Action Indicated (VAI)
Premier Produce ServicesFood/Cosmetics05/02/2023Voluntary Action Indicated (VAI)
Prime Supply Distro, LLCTobacco06/09/2023Voluntary Action Indicated (VAI)
Pure Gen Holdings, Inc.Food/Cosmetics08/18/2023No Action Indicated (NAI)
RP Foods, LLCFood/Cosmetics07/06/2023Voluntary Action Indicated (VAI)
Renfro Foods, Inc.Food/Cosmetics08/31/2023Voluntary Action Indicated (VAI)
Restaurant DepotFood/Cosmetics01/20/2023No Action Indicated (NAI)
Saddle Creek Logistic ServicesFood/Cosmetics10/30/2023No Action Indicated (NAI)
Saddle Creek Logistics ServicesFood/Cosmetics07/06/2023No Action Indicated (NAI)
Select CorporationDrugs09/14/2023Voluntary Action Indicated (VAI)
Selery Fulfillment, Inc.Food/Cosmetics04/12/2023Voluntary Action Indicated (VAI)
Signature Flight SupportFood/Cosmetics05/16/2023No Action Indicated (NAI)
Somnomed, Inc.Devices03/16/2023No Action Indicated (NAI)
SouQ El Sudan, Inc.Food/Cosmetics09/08/2023Voluntary Action Indicated (VAI)
Southwest AirlinesFood/Cosmetics01/25/2023No Action Indicated (NAI)
Southwest Transplant Alliance, Inc.Biologics02/03/2023No Action Indicated (NAI)
Sovereign Pharmaceuticals, LLCDrugs08/02/2023Official Action Indicated (OAI)
St. Charles Trading, Inc.Food/Cosmetics08/14/2023No Action Indicated (NAI)
Steri-Tek, LLCDevices09/26/2023Voluntary Action Indicated (VAI)
Sterigenics US, LLCDevices08/17/2023Voluntary Action Indicated (VAI)
Storm Chaser, Corp.Tobacco04/03/2023Voluntary Action Indicated (VAI)
Taka USA, Inc.Drugs02/07/2023Official Action Indicated (OAI)
Taylor Farms TexasFood/Cosmetics09/06/2023No Action Indicated (NAI)
Taylor Farms Texas, Inc.Food/Cosmetics09/12/2023No Action Indicated (NAI)
The Morrison Milling CompanyFood/Cosmetics10/25/2023No Action Indicated (NAI)
The Sygma NetworkFood/Cosmetics01/19/2023No Action Indicated (NAI)
Third Coast Marketing Holdings, LPFood/Cosmetics08/03/2023Voluntary Action Indicated (VAI)
Timothy E. Ritter, M.D.Drugs03/30/2023No Action Indicated (NAI)
UT Southwestern Medical CenterBiologics04/05/2023No Action Indicated (NAI)
Unifi Aviation, LLCFood/Cosmetics01/25/2023Voluntary Action Indicated (VAI)
United Laboratories Manufacturing, LLCFood/Cosmetics05/09/2023No Action Indicated (NAI)
University of Texas Southwestern Medical Center, TheDevices02/09/2023No Action Indicated (NAI)
VA - North Texas Health Care SystemBiologics04/10/2023No Action Indicated (NAI)
Value Feeds, LLCVeterinary07/06/2023No Action Indicated (NAI)
West Pak AvocadoFood/Cosmetics10/25/2023No Action Indicated (NAI)
WildMillet, LLCFood/Cosmetics04/10/2023No Action Indicated (NAI)
Yi Group, Inc.Food/Cosmetics09/15/2023Voluntary Action Indicated (VAI)

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