Toledo Reporter

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

The citations in the county include:

• Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system.
• Quality audits have not been performed.
• Risk analysis is inadequate.

The company cited was involved in the Devices sector.

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
R-Med, Inc.	Devices	04/23/2025	Management review - defined interval, sufficient frequency
R-Med, Inc.	Devices	04/23/2025	Quality Audit/Reaudit - conducted
R-Med, Inc.	Devices	04/23/2025	Design Validation - Risk analysis not performed/inadequate
R-Med, Inc.	Devices	04/23/2025	Design history file
R-Med, Inc.	Devices	04/23/2025	Lack of or inadequate procedures - Acceptance activities
R-Med, Inc.	Devices	04/23/2025	Nonconforming product, Lack of or inadequate procedures
R-Med, Inc.	Devices	04/23/2025	DMR - not or inadequately maintained
R-Med, Inc.	Devices	04/23/2025	DHR - not or inadequately maintained
R-Med, Inc.	Devices	04/23/2025	Complaints
R-Med, Inc.	Devices	04/23/2025	Statistical techniques - Lack of or inadequate procedures