Dupage Policy Journal

There were seven companies in cities associated with DuPage County that received FDA citations as a result of seven inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 58.8% decrease from the number of companies cited in the previous quarter.

Of the 20 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

Most of the companies cited were involved in the Devices sector.

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.

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
Conagra Brands, Inc.	Food and Cosmetics	11/22/2023	Identification - entry
Fertility Centers of Illinois	Biologics	10/18/2023	Donor screening standards
Fertility Centers of Illinois	Biologics	10/18/2023	Reasons for ineligibility on summary
Fertility Centers of Illinois	Biologics	10/18/2023	Labeled re: biohazard, risks, test results
Grafton Medical Alliance	Devices	10/26/2023	Lack of or inadequate procedures
Grafton Medical Alliance	Devices	10/26/2023	Complaints
Institute for Human Reproduction, School	Biologics	10/25/2023	Testing, screening, donor eligibility procedures
Institute for Human Reproduction, School	Biologics	10/25/2023	Donor screening standards
Institute for Human Reproduction, School	Biologics	10/25/2023	Statement re: certified testing lab
Institute for Human Reproduction, School	Biologics	10/25/2023	Completion of eligibility determination
Instrumed International, Inc.	Devices	12/05/2023	Document locations, Dissemination, etc.
Instrumed International, Inc.	Devices	12/05/2023	Purchasing controls, Lack of or inadequate procedures
Instrumed International, Inc.	Devices	12/05/2023	Product rework procedures, Lack of or inadequate procedures
Instrumed International, Inc.	Devices	12/05/2023	Lack of or inadequate procedures
Instrumed International, Inc.	Devices	12/05/2023	Documentation
Stericycle, Inc.	Devices	12/21/2023	Management review - defined interval, sufficient frequency
Stericycle, Inc.	Devices	12/21/2023	Quality audits - Lack of or inadequate procedures
Stericycle, Inc.	Devices	12/21/2023	Lack of or inadequate procedures
V & G Commerce, LLC	Food and Cosmetics	12/18/2023	Develop FSVP
V & G Commerce, LLC	Food and Cosmetics	12/18/2023	Hazard analysis biological, chemical, physical