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.
| 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 |



