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Thursday, November 21, 2024

How many companies in cities across Harris County received FDA citations in Q3?

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

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

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

This is a 62.5% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

  • Your hazard analysis did not identify a hazard that requires a control.
  • You did not conduct and document or obtain documentation of one or more supplier verification activities before importing the food into the United States.
  • You did not make a required FSVP record available to an authorized FDA representative upon request.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).

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 Harris County Cities and the citations they received in Q3
Company NameArea of BusinessInspection DateIssue Cited
Airgas USA, LLCDrugs08/15/2024Records reviewed annually
Airgas USA, LLCDrugs08/15/2024Records of disposition of rejected material
Tropical Growers Direct, LLCFood and Cosmetics09/12/2024Hazard analysis biological, chemical, physical
Tropical Growers Direct, LLCFood and Cosmetics09/12/2024Verification activity before import, periodically
Tropical Growers Direct, LLCFood and Cosmetics09/12/2024Record - available
Winfull CorporationFood and Cosmetics07/26/2024Develop FSVP

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