West DSM News

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Kathleen Jones, Clinical Investigator, M.D.	Biologics	01/13/2023	FD-1572, protocol compliance
Midwest Foods, LLC	Food and Cosmetics	12/13/2023	Process adherence
Midwest Foods, LLC	Food and Cosmetics	12/13/2023	Process deviation
Midwest Foods, LLC	Food and Cosmetics	12/13/2023	Process preventive controls - Implement
Rio Verde Foods Service	Food and Cosmetics	06/02/2023	Hazard analysis - Conducted