Wayne County Today

There was one company in a city associated with Wayne County that received FDA citations as a result of one inspection conducted in the county over the second quarter of 2025, 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:

• There is no record maintained of a correction or removal action that was not required to be reported to FDA.
• A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
• Corrective and preventive action activities and/or results have not been 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.

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
Prentke Romich Company	Devices	05/01/2025	Records not kept
Prentke Romich Company	Devices	05/01/2025	Lack of or inadequate process validation
Prentke Romich Company	Devices	05/01/2025	Documentation
Prentke Romich Company	Devices	05/01/2025	Lack of or inadequate DHR procedures
Prentke Romich Company	Devices	05/01/2025	Lack of or inadequate complaint procedures