North Cook News

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

This is a 500% increase over the number of companies cited in the previous month.

The citations in the county include:

• Written procedures have not been developed for the surveillance, receipt and evaluation of post marketing adverse drug experiences.
• Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up.

All of the companies cited were involved in either Drugs, Biologics, or Devices sectors.

All of the 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
Advocate Lutheran General Hospital Transfusion Services	Biologics	12/05/2024	Procedures to maintain records of emergency transfusions
Bajaj Medical, LLC	Drugs	12/04/2024	Failure to develop written procedures
Jeron Electronic Systems, Inc.	Devices	12/04/2024	Documentation
Loyola University Medical Center	Biologics	12/05/2024	Maintenance - concurrence
Loyola University Medical Center	Biologics	12/05/2024	Establish, maintain and follow manufacturing SOPs
Sterigenics International, LLC	Devices	12/17/2024	Lack of or inadequate procedures
Vee Pak, LLC	Drugs	12/10/2024	Scientifically sound laboratory controls
Vee Pak, LLC	Drugs	12/10/2024	Written record of investigation incomplete