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Tuesday, November 5, 2024

How many FDA citations were issued in cities within Denton County in February

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

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

This is a 50% increase over the number of companies cited in the previous month.

The citations in the county include:

  • You did not store or transport a food under conditions that protect against allergen cross-contact, contamination and deterioration.
  • Written standard operating procedures including all steps to be followed in the storage of blood and blood components for further manufacturing purposes were not always followed.
  • You did not establish and maintain procedures for testing of HCT/P donors.

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 February
Company NameArea of BusinessInspection DateIssue Cited
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
Five Star Produce PlusFood and Cosmetics02/28/2024Storage and Distribution

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