Elkhart Times

There was one company in a city associated with Elkhart 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 unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

• A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
• A validated process was not reviewed and evaluated when changes or process deviations occurred.
• Procedures have not been established to control product that does not conform to specified requirements.

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.

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
Arch Medical Solutions - Elkhart	Devices	12/18/2024	Lack of or inadequate process validation
Arch Medical Solutions - Elkhart	Devices	12/18/2024	Process changes - review, evaluation and revalidation
Arch Medical Solutions - Elkhart	Devices	12/18/2024	Nonconforming product, Lack of or inadequate procedures
Arch Medical Solutions - Elkhart	Devices	12/18/2024	Lack of or inadequate complaint procedures