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Thursday, October 31, 2024

How many FDA citations were issued in cities within Tarrant County in 2023

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

There were 19 companies in cities associated with Tarrant County that received FDA citations as a result of 19 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 35.7% increase over the number of companies cited in the previous year.

Of the 77 citations issued, the most common citations include:

  • You did not keep the grounds around your plant in a condition that would protect against the contamination of food.
  • You did not maintain your plant in a clean and sanitary condition and in adequate repair.
  • You did not exclude pests from your food plant to protect against contamination of food.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.

Of the companies cited, 17 should take voluntary actions to correct their managing operations (89.5%). Additionally, two companies had to take regulatory and/or administrative actions (10.5%).

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 Within Tarrant County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Amcor Rigid Packaging USA, LLCDevices01/12/2023Evaluation of suppliers, contractors, etc., requirements
Amcor Rigid Packaging USA, LLCDevices01/12/2023Nonconforming product, Lack of or inadequate procedures
Amcor Rigid Packaging USA, LLCDevices01/12/2023Lack of or inadequate complaint procedures
Anbar Distributions, LLCFood and Cosmetics08/17/2023Very small importer assurances, supplier
Biscuits & Cookies InternationalFood and Cosmetics08/15/2023Supplier approval - document
Biscuits & Cookies InternationalFood and Cosmetics08/15/2023Approved supplier procedures - importer established
Biscuits & Cookies InternationalFood and Cosmetics08/15/2023Supplier verification - establish written procedures
Biscuits & Cookies InternationalFood and Cosmetics08/15/2023Record - English
Brian FlowersDrugs03/23/2023FD-1572, protocol compliance
Dart Container CorporationFood and Cosmetics08/25/2023Hazard analysis written
Dart Container CorporationFood and Cosmetics08/25/2023Evaluation - performance, risk
Dart Container CorporationFood and Cosmetics08/25/2023Verification activity assurance
Dart Container CorporationFood and Cosmetics08/25/2023Verification activity before import, periodically
Fruit Of The Earth Research Laboratories, Inc.Drugs03/31/2023Buildings not maintained in good state of repair
Inmar Supply Chain Solutions, LLCDevices07/19/2023Grounds
Inmar Supply Chain Solutions, LLCDevices07/19/2023Sanitary operations - Plant maintenance
Inmar Supply Chain Solutions, LLCDevices07/19/2023Pest control
Inmar Supply Chain Solutions, LLCDevices07/19/2023Procedures not in writing, fully followed
Inmar Supply Chain Solutions, LLCDevices07/19/2023Sanitation--buildings not clean, free of infestation
Inmar Supply Chain Solutions, LLCDevices07/19/2023Buildings not maintained in good state of repair
Inmar Supply Chain Solutions, LLCDevices07/19/2023Storage under appropriate conditions
Inmar Supply Chain Solutions, LLCDevices07/19/2023Distribution Record Requirements
Inmar Supply Chain Solutions, LLCDevices07/19/2023Salvaging and return to marketplace
Inmar Supply Chain Solutions, LLCDevices07/19/2023Insanitary Conditions (FDCA 501(a)(2)(A))
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Grounds
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Sanitary operations - Plant maintenance
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Pest control
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Procedures not in writing, fully followed
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Sanitation--buildings not clean, free of infestation
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Buildings not maintained in good state of repair
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Storage under appropriate conditions
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Distribution Record Requirements
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Salvaging and return to marketplace
Inmar Supply Chain Solutions, LLCDrugs07/19/2023Insanitary Conditions (FDCA 501(a)(2)(A))
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Grounds
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Sanitary operations - Plant maintenance
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Pest control
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Procedures not in writing, fully followed
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Sanitation--buildings not clean, free of infestation
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Buildings not maintained in good state of repair
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Storage under appropriate conditions
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Distribution Record Requirements
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Salvaging and return to marketplace
Inmar Supply Chain Solutions, LLCFood and Cosmetics07/19/2023Insanitary Conditions (FDCA 501(a)(2)(A))
Lucid Wellness, LLCFood and Cosmetics02/17/2023Quality control - quality, dietary supplement
Lucid Wellness, LLCFood and Cosmetics02/17/2023Reserve sample - collect, hold
Lucid Wellness, LLCFood and Cosmetics02/17/2023Written procedures - holding
Lucid Wellness, LLCFood and Cosmetics02/17/2023Written procedures - returned dietary supplement
Lucid Wellness, LLCFood and Cosmetics02/17/2023Written procedures - product complaint
Mannatech IncorporatedFood and Cosmetics09/13/2023Develop FSVP
Marriott International, Inc.Food and Cosmetics11/13/2023Identification - entry
Marriott International, Inc.Food and Cosmetics11/13/2023Regulatory oversight
Mid-States Distributing, LLCVeterinary09/11/2023Document review entity's hazard analysis
Mid-States Distributing, LLCVeterinary09/11/2023Evaluation - performance, risk
Mid-States Distributing, LLCVeterinary09/11/2023Verification activity before import, periodically
Mission Produce, Inc.Food and Cosmetics06/06/2023Sanitary facilities and controls
Mtek Group, LLCFood and Cosmetics09/27/2023Approved supplier procedures - importer established
Nelson Enviromental Technologies, Inc.Devices10/10/2023Purchasing controls, Lack of or inadequate procedures
Nurse Assist, LLCDevices09/21/2023Individual Report of Malfunction
Nurse Assist, LLCDevices09/21/2023Training - Lack of or inadequate procedures
Nurse Assist, LLCDevices09/21/2023Design Validation - Risk analysis not performed/inadequate
Nurse Assist, LLCDevices09/21/2023Purchasing controls, Lack of or inadequate procedures
Nurse Assist, LLCDevices09/21/2023Contamination control, Lack of or inadequate procedures
Nurse Assist, LLCDevices09/21/2023Maintenance schedule, Lack of or inadequate schedule
Nurse Assist, LLCDevices09/21/2023Calibration, Inspection, etc. Procedures Lack of or Inadequ
Nurse Assist, LLCDevices09/21/2023Lack of or inadequate process validation
Nurse Assist, LLCDevices09/21/2023Lack/Inad procedure-Monitoring/Control of Validated Proces
Nurse Assist, LLCDevices09/21/2023Nonconforming product, Lack of or inadequate procedures
Nurse Assist, LLCDevices09/21/2023Lack of or inadequate procedures
Premier Produce ServicesFood and Cosmetics05/02/2023Supplier approval - document
Premier Produce ServicesFood and Cosmetics05/02/2023Onsite audit
Pulido Associates, Inc.Food and Cosmetics04/20/2023Toxic chemicals - Identified, held, stored
Pulido Associates, Inc.Food and Cosmetics04/20/2023Hazard analysis - Conducted
Pulido Associates, Inc.Food and Cosmetics04/20/2023Sanitation preventive controls - Implement
Renfro Foods, Inc.Food and Cosmetics08/31/2023Process deviation
Renfro Foods, Inc.Food and Cosmetics08/31/2023Qualifications of individuals
Talia Foods, LLCFood and Cosmetics09/15/2023Develop FSVP

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