North Cook News

There were two companies in cities associated with DuPage County that received FDA citations as a result of two inspections conducted in the county in December 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous month.

The citations in the county were 'Written procedures have not been developed for the surveillance, receipt and evaluation of post marketing adverse drug experiences' and 'Procedures for corrective and preventive action have not been adequately established'.

Both companies cited should take voluntary actions to correct their 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
Bajaj Medical, LLC	Drugs	12/04/2024	Failure to develop written procedures
Sterigenics International, LLC	Devices	12/17/2024	Lack of or inadequate procedures