Dallas City Wire

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

This is a 300% increase over the number of companies cited in the previous month.

The citations in the county include:

• Procedures for management review have not been adequately established.
• Procedures for quality audits have not been established.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.

All of the companies cited were involved in either Devices or Food and Cosmetics sectors.

All of the companies cited should take voluntary actions to correct their managing operations.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
ABC Food Trading, LLC	Food and Cosmetics	01/12/2024	Sanitary operations - Plant maintenance
AutoMedx, LLC	Devices	01/18/2024	Management review - Lack of or inadequate procedures
AutoMedx, LLC	Devices	01/18/2024	Quality audits - Lack of or inadequate procedures
AutoMedx, LLC	Devices	01/18/2024	Purchasing controls, Lack of or inadequate procedures
AutoMedx, LLC	Devices	01/18/2024	Lack of or inadequate complaint procedures
Bound Tree Medical, LLC	Devices	01/31/2024	Evaluation and Selection, Suppliers, Contractors, etc.
Bound Tree Medical, LLC	Devices	01/31/2024	Nonconforming product, Lack of or inadequate procedures
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