Kenosha Reporter

There was one company in a city associated with Kenosha County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous quarter.

The citations in the county include:

• 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.
• Process validation activities have not been adequately documented.

The company cited should take a voluntary action to correct its 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.

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