How many companies in cities across Rockwall County received FDA citations in 2024?

How many companies in cities across Rockwall County received FDA citations in 2024?
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer — Official Website
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There were 21 companies in cities associated with Rockwall County that received FDA citations as a result of 22 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 4.5% decrease from the number of companies cited in the previous year.

Of the 69 citations issued, the most common citations include:

  • You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier’s performance and the risk posed by a food.
  • A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
  • Your plant did not have adequate sanitary facilities and accommodations.

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 Biologics sector.

Of the companies cited, 19 should take voluntary actions to correct their managing operations (90.5%). Additionally, two companies had to take regulatory and/or administrative actions (9.5%).

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.

According to its website, 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.

Companies Located Within Rockwall County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
ABC Food Trading, LLC Food and Cosmetics 01/12/2024 Sanitary operations – Plant maintenance
AmWiner & Raphe Holdings, LLC Drugs 08/07/2024 Procedures not in writing, fully followed
AmWiner & Raphe Holdings, LLC Drugs 08/07/2024 Cleaning / Sanitizing / Maintenance
AmWiner & Raphe Holdings, LLC Drugs 08/07/2024 Reports of Analysis (Components)
AmWiner & Raphe Holdings, LLC Drugs 08/07/2024 Control procedures to monitor and validate performance
AmWiner & Raphe Holdings, LLC Drugs 08/07/2024 Testing and release for distribution
AmWiner & Raphe Holdings, LLC Drugs 08/07/2024 Lack of written stability program
Baylab USA, LLC Devices 01/31/2024 Label to bear a unique device identifier
Baylab USA, LLC Devices 01/31/2024 Lack of Written MDR Procedures
Baylab USA, LLC Devices 01/31/2024 Quality Audits – defined intervals
Baylab USA, LLC Devices 01/31/2024 Training – Lack of or inadequate procedures
Baylab USA, LLC Devices 01/31/2024 Design control – no procedures
Baylab USA, LLC Devices 01/31/2024 Purchasing controls, Lack of or inadequate procedures
Baylab USA, LLC Devices 01/31/2024 Lack of or inadequate process validation
Baylab USA, LLC Devices 01/31/2024 Lack of or inadequate procedures
Baylab USA, LLC Devices 01/31/2024 GUDID Information required for unique device identification.
CSL Plasma, Inc. Biologics 02/01/2024 Establish, maintain and follow manufacturing SOPs
Costco Wholesale #288 Food and Cosmetics 06/28/2024 HACCP plan implementation
Costco Wholesale #288 Food and Cosmetics 06/28/2024 Critical limits
Costco Wholesale #288 Food and Cosmetics 06/28/2024 Monitoring – adequacy
Costco Wholesale #288 Food and Cosmetics 06/28/2024 Verification – recordkeeping
Costco Wholesale #288 Food and Cosmetics 11/13/2024 Critical limits
Cucina Antica Foods, Corp. Food and Cosmetics 02/29/2024 Hazard analysis written
Cucina Antica Foods, Corp. Food and Cosmetics 02/29/2024 Evaluation – performance, risk
Cucina Antica Foods, Corp. Food and Cosmetics 02/29/2024 Verification activity assurance
Dairyland Produce, LLC Food and Cosmetics 04/01/2024 Storage and Distribution
Eurofins Donor & Product Testing Dallas, Inc. Biologics 03/05/2024 Manufacturer instructions not followed
Eurofins Donor & Product Testing Dallas, Inc. Biologics 03/05/2024 Actions verified, short and long term solutions
Eurofins Donor & Product Testing Dallas, Inc. Biologics 03/05/2024 Deviations–evaluation, cause, corrective action
Eurofins Donor & Product Testing Dallas, Inc. Biologics 03/05/2024 Design appropriate, suitably located
Garland Ventures, Ltd. Food and Cosmetics 04/19/2024 Hazard analysis – Identification of hazard
Garland Ventures, Ltd. Food and Cosmetics 04/19/2024 Allergen preventive controls – Appropriate (Adequate)
Garland Ventures, Ltd. Food and Cosmetics 04/19/2024 Sanitation preventive controls – Appropriate (Adequate)
Herbal Natural Solutions, Inc. Food and Cosmetics 11/07/2024 Quality control operations – material review, disposition
Mozzarella Company Food and Cosmetics 01/17/2024 Sanitary operations – Plant sanitation
Mozzarella Company Food and Cosmetics 01/17/2024 Sanitary facilities and controls
Mozzarella Company Food and Cosmetics 01/17/2024 Plant operations – Precautions
Mozzarella Company Food and Cosmetics 01/17/2024 Manufacturing, processing, packing, holding – Controls
Mozzarella Company Food and Cosmetics 01/17/2024 Qualified facility – Attestation
Octapharma Plasma, Inc. Biologics 03/22/2024 Provide proper equipment to meet requirements
Philip NMI Raskin Drugs 01/11/2024 FD-1572, protocol compliance
Rancho Santo Cristo, Inc. Food and Cosmetics 06/17/2024 Qualifications of individuals
Rancho Santo Cristo, Inc. Food and Cosmetics 06/17/2024 Sanitary operations – Plant maintenance
Rancho Santo Cristo, Inc. Food and Cosmetics 06/17/2024 Sanitary facilities and controls
Rancho Santo Cristo, Inc. Food and Cosmetics 06/17/2024 Hazard analysis – Identification of hazard
Rancho Santo Cristo, Inc. Food and Cosmetics 06/17/2024 Reportable food report – submission
Regalis Texas, LLC Food and Cosmetics 03/19/2024 Sanitary operations – Plant maintenance
Regalis Texas, LLC Food and Cosmetics 03/19/2024 HACCP plan implementation
Regalis Texas, LLC Food and Cosmetics 03/19/2024 Signed and dated
Regalis Texas, LLC Food and Cosmetics 03/19/2024 Calibration – adequacy
Regalis Texas, LLC Food and Cosmetics 03/19/2024 Sanitation Records
Sharma Vishal, LLC Food and Cosmetics 10/09/2024 Grounds
Sharma Vishal, LLC Food and Cosmetics 10/09/2024 Pest control
Sharma Vishal, LLC Food and Cosmetics 10/09/2024 Manufacturing, processing, packing, holding – Controls
SmartSurg Medical Supply, LLC Biologics 08/29/2024 Temperature limits
SmartSurg Medical Supply, LLC Biologics 08/29/2024 Records incomplete
Sohgave, LLC Food and Cosmetics 04/30/2024 Hazard analysis biological, chemical, physical
Sohgave, LLC Food and Cosmetics 04/30/2024 Evaluation – performance, risk
Sohgave, LLC Food and Cosmetics 04/30/2024 Supplier verification – establish written procedures
Sohgave, LLC Food and Cosmetics 04/30/2024 Verification activity assurance
Sohgave, LLC Food and Cosmetics 04/30/2024 Verification activity before import, periodically
Sohgave, LLC Food and Cosmetics 04/30/2024 Identification – entry
Taxco Produce, Inc. Food and Cosmetics 02/20/2024 Sanitary operations – Plant maintenance
Taxco Produce, Inc. Food and Cosmetics 02/20/2024 Food safety plan
Van Duzen, Inc. Devices 08/02/2024 Lack of or inadequate process validation
Welcome Bread Company, LLC Food and Cosmetics 08/09/2024 Raw materials controls – Natural toxins
Welcome Bread Company, LLC Food and Cosmetics 08/09/2024 Raw materials – Allergen identification
Welcome Bread Company, LLC Food and Cosmetics 08/09/2024 Manufacturing, processing, packing, holding – Controls
Welcome Bread Company, LLC Food and Cosmetics 08/09/2024 Training records – General requirements


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