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Thursday, November 7, 2024

FDA: 8 companies in cities within Dallas County received 18 citations in Q4 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

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.

Companies located within Dallas County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
Buda Juice, LLCFood and Cosmetics11/14/2023HACCP plan - monitoring procedures - none listed
Buda Juice, LLCFood and Cosmetics11/14/2023HACCP plan - corrective action plan not included
Divine Design ManufacturingFood and Cosmetics11/21/2023Specifications - component identity
Divine Design ManufacturingFood and Cosmetics11/21/2023Specifications - identity, purity, strength, composition
Divine Design ManufacturingFood and Cosmetics11/21/2023Component - verify identity, dietary ingredient
Divine Design ManufacturingFood and Cosmetics11/21/2023Documentation - qualify supplier
Fertility and Advanced Reproductive Medicine at UTSWBiologics12/13/2023Donor testing not negative for CD agents
Fertility and Advanced Reproductive Medicine at UTSWBiologics12/13/2023Documentation--determination, by whom, date
Fertility and Advanced Reproductive Medicine at UTSWBiologics12/13/2023Risk factors, clinical evidence
Fertility and Advanced Reproductive Medicine at UTSWBiologics12/13/2023Eligibility not required--warning labels
La Fabrica, LLCFood and Cosmetics11/06/2023Manufacturing, processing, packing, holding - Controls
Marriott International, Inc.Food and Cosmetics11/13/2023Identification - entry
Marriott International, Inc.Food and Cosmetics11/13/2023Regulatory oversight
Mary Kay, Inc.Drugs10/27/2023Cleaning SOPs/equipment protection
Parvez MantryDrugs11/14/2023FD-1572, protocol compliance
Post Oak Innovations, Inc.Devices10/13/2023Document change records, maintained.
Post Oak Innovations, Inc.Devices10/13/2023Acceptable supplier records, inadequate records
Post Oak Innovations, Inc.Devices10/13/2023Lack of or inadequate procedures

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