Whitewater Times

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

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county include:

• You did not develop an FSVP.
• Procedures for training and identifying training needs have not been adequately established.
• Software used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.

Both 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.

According to its website, 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Commercial Plastics, LLC	Devices	11/07/2024	Training - Lack of or inadequate procedures
Commercial Plastics, LLC	Devices	11/07/2024	Software validation for automated processes
Commercial Plastics, LLC	Devices	11/07/2024	Documentation
Commercial Plastics, LLC	Devices	11/07/2024	Lack of or inadequate final acceptance procedures
Commercial Plastics, LLC	Devices	11/07/2024	Nonconforming product, Lack of or inadequate procedures
Robinson Wholesale Bait, LLC	Veterinary	05/09/2024	Develop FSVP