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Mid City Times

Thursday, November 21, 2024

Companies across Dallas County cities saw 17 FDA citations in Q2

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Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

There were five companies in cities associated with Dallas County that received FDA citations as a result of five inspections conducted in the county over the second quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 37.5% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

  • Your quality control personnel did not conduct required material reviews.
  • Your master manufacturing record did not include a description of the packaging and a representative label, or a cross-reference to the physical location of the actual or representative label.
  • You did not develop an FSVP.

Most of the companies cited were involved in the Food and Cosmetics sector.

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 Q2
Company NameArea of BusinessInspection DateIssue Cited
Bonafide Innovations, LLCDrugs05/06/2024GMP Training Frequency
Bonafide Innovations, LLCDrugs05/06/2024Buildings of Suitable Size, Construction, Location
Bonafide Innovations, LLCDrugs05/06/2024Written procedures not established/followed
Dairyland Produce, LLCFood and Cosmetics04/01/2024Storage and Distribution
FMT Services, LLCFood and Cosmetics05/02/2024Develop FSVP
FMT Services, LLCFood and Cosmetics05/02/2024Hazard analysis written
FMT Services, LLCFood and Cosmetics05/02/2024Supplier approval - document
FMT Services, LLCFood and Cosmetics05/02/2024Reevaluate - 3 years
FMT Services, LLCFood and Cosmetics05/02/2024Approved supplier procedures - importer established
FMT Services, LLCFood and Cosmetics05/02/2024Supplier verification - establish written procedures
FMT Services, LLCFood and Cosmetics05/02/2024Verification activity assurance
FMT Services, LLCFood and Cosmetics05/02/2024Verification activity before import, periodically
Garland Ventures, Ltd.Food and Cosmetics04/19/2024Hazard analysis - Identification of hazard
Garland Ventures, Ltd.Food and Cosmetics04/19/2024Allergen preventive controls - Appropriate (Adequate)
Garland Ventures, Ltd.Food and Cosmetics04/19/2024Sanitation preventive controls - Appropriate (Adequate)
Trace Elements, Inc.Food and Cosmetics06/11/2024Material review, disposition - quality control
Trace Elements, Inc.Food and Cosmetics06/11/2024Packaging description, representative label

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