Dayton Reporter

There was one company in a city associated with Montgomery County that received FDA citations as a result of one inspection conducted in the county over the third quarter of 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 quarter.

The citations in the county include:

• Evaluations of out-of-calibration equipment and remedial actions taken were not documented.
• Corrective and preventive action activities and/or results have not been adequately documented.
• Complaint files are not adequately maintained.

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
Paragon Medical - Dayton	Devices	09/06/2024	Remedial action - documentation
Paragon Medical - Dayton	Devices	09/06/2024	Documentation
Paragon Medical - Dayton	Devices	09/06/2024	Complaints