NE Dallas News

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

This is a 57.9% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• You did not ensure that your electronic mail address were provided electronically when filing entry with the U.S. Customs and Border Protection.
• You did not document that the foreign supplier is in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, and that the food is within the scope of FDA's official recognition or equivalency determination before importing a food from a foreign supplier and on an annual basis.
• Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.

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 .

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
Buda Juice, LLC	Food and Cosmetics	11/14/2023	HACCP plan - monitoring procedures - none listed
Buda Juice, LLC	Food and Cosmetics	11/14/2023	HACCP plan - corrective action plan not included
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Specifications - component identity
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Specifications - identity, purity, strength, composition
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Component - verify identity, dietary ingredient
Divine Design Manufacturing	Food and Cosmetics	11/21/2023	Documentation - qualify supplier
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Donor testing not negative for CD agents
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Documentation--determination, by whom, date
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Risk factors, clinical evidence
Fertility and Advanced Reproductive Medicine at UTSW	Biologics	12/13/2023	Eligibility not required--warning labels
La Fabrica, LLC	Food and Cosmetics	11/06/2023	Manufacturing, processing, packing, holding - Controls
Marriott International, Inc.	Food and Cosmetics	11/13/2023	Identification - entry
Marriott International, Inc.	Food and Cosmetics	11/13/2023	Regulatory oversight
Mary Kay, Inc.	Drugs	10/27/2023	Cleaning SOPs/equipment protection
Parvez Mantry	Drugs	11/14/2023	FD-1572, protocol compliance
Post Oak Innovations, Inc.	Devices	10/13/2023	Document change records, maintained.
Post Oak Innovations, Inc.	Devices	10/13/2023	Acceptable supplier records, inadequate records
Post Oak Innovations, Inc.	Devices	10/13/2023	Lack of or inadequate procedures