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Companies across Denton County cities saw 19 FDA citations in Q1

Business

By Collin Times | Apr 23, 2024

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

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

This is a 28.6% increase over the number of companies cited in the previous quarter.

Of the 19 citations issued, the most common citation was 'HCT/P donors were not determined to be eligible based on the results of donor screening and testing'.

Most of the companies cited were involved in the Biologics 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 Denton County Cities and the citations they received in Q1
Company NameArea of BusinessInspection DateIssue Cited
ABC Food Trading, LLCFood and Cosmetics01/12/2024Sanitary operations - Plant maintenance
Alfred J. Rodriguez, P. A., M.D.Biologics02/27/2024Testing, screening, donor eligibility procedures
Alfred J. Rodriguez, P. A., M.D.Biologics02/27/2024Determination based on screening and testing
Alfred J. Rodriguez, P. A., M.D.Biologics02/27/2024Responsible person to determine, document
CSL Plasma, Inc.Biologics02/01/2024Establish, maintain and follow manufacturing SOPs
Dallas IVFBiologics03/28/2024Determination based on screening and testing
Eurofins Donor & Product Testing Dallas, Inc.Biologics03/05/2024Manufacturer instructions not followed
Eurofins Donor & Product Testing Dallas, Inc.Biologics03/05/2024Actions verified, short and long term solutions
Eurofins Donor & Product Testing Dallas, Inc.Biologics03/05/2024Deviations--evaluation, cause, corrective action
Eurofins Donor & Product Testing Dallas, Inc.Biologics03/05/2024Design appropriate, suitably located
Five Star Produce PlusFood and Cosmetics02/28/2024Storage and Distribution
Mozzarella CompanyFood and Cosmetics01/17/2024Sanitary operations - Plant sanitation
Mozzarella CompanyFood and Cosmetics01/17/2024Sanitary facilities and controls
Mozzarella CompanyFood and Cosmetics01/17/2024Plant operations - Precautions
Mozzarella CompanyFood and Cosmetics01/17/2024Manufacturing, processing, packing, holding - Controls
Mozzarella CompanyFood and Cosmetics01/17/2024Qualified facility - Attestation
Octapharma Plasma, Inc.Biologics03/22/2024Provide proper equipment to meet requirements
Steri-Tek, LLCBiologics03/26/2024Process validation procedures
Steri-Tek, LLCBiologics03/26/2024Storage temperatures recorded, maintained

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Organizations in this Story

City of Fort WorthCity of LewisvilleCity of PlanoCity of Dallas

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