North Cook News

There were eight companies in cities associated with Cook County that received FDA citations as a result of eight 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 66.7% decrease from the number of companies cited in the previous quarter.

Of the 19 citations issued, the most common citations include:

• You did not develop an FSVP.
• Procedures for corrective and preventive action have not been adequately established.
• Donor screening of HCT/P donors considered eligible indicated that the donor was not free of risk factors for infection due to communicable disease agents.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the .

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
Cheshni Foods, LLC	Food and Cosmetics	11/17/2023	Develop FSVP
Cheshni Foods, LLC	Food and Cosmetics	11/17/2023	Very small importer assurances, supplier
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
FiMex, Inc.	Food and Cosmetics	10/20/2023	Develop FSVP
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
Vee Pak, LLC	Drugs	12/11/2023	Valid stability test methods