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Thursday, November 21, 2024

How many companies in cities across Polk County received FDA citations in 2023?

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

There were three companies in cities associated with Polk County that received FDA citations as a result of three inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 200% increase over the number of companies cited in the previous year.

The citations in the county include:

  • You did not process a food in conformity with at least the scheduled process filed with FDA.
  • When a process operation deviated from the scheduled process or the equilibrium pH of the finished product was higher than 4.6, you did not fully reprocess the food by a process established by a competent processing authority as adequate to ensure a safe product; or thermally process the food as required for low-acid food; or set aside the food for further evaluation as to any potential public health significance.
  • You did not implement your process preventive control, monitoring and verification procedures.

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 Polk County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Kathleen Jones, Clinical Investigator, M.D.Biologics01/13/2023FD-1572, protocol compliance
Midwest Foods, LLCFood and Cosmetics12/13/2023Process adherence
Midwest Foods, LLCFood and Cosmetics12/13/2023Process deviation
Midwest Foods, LLCFood and Cosmetics12/13/2023Process preventive controls - Implement
Rio Verde Foods ServiceFood and Cosmetics06/02/2023Hazard analysis - Conducted

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