McHenry Times

There was one company in a city associated with Kane 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 were 'An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur' and 'Investigation records of MDR reportable complaints do not include required information'.

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
Life Spine, LLC.	Devices	05/02/2025	Individual Report of Malfunction
Life Spine, LLC.	Devices	05/02/2025	Records of MDR Investigation