North Cook News

There were 35 companies in cities associated with Cook County that received FDA citations as a result of 35 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 52.1% decrease from the number of companies cited in the previous year.

Of the 96 citations issued, the most common citation was 'You did not develop an FSVP'.

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 Drugs sector.

Of the companies cited, 30 should take voluntary actions to correct their managing operations (85.7%). Additionally, six companies had to take regulatory and/or administrative actions (17.1%).

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
A. B. Company, Inc.	Food and Cosmetics	03/22/2024	Develop FSVP
Advocate Lutheran General Hospital Transfusion Services	Biologics	12/05/2024	Procedures to maintain records of emergency transfusions
Amtrak Maintenance Facility	Food and Cosmetics	05/29/2024	Clean and free from flies, rodents, and other vermin
Amtrak Maintenance Facility	Food and Cosmetics	05/29/2024	Connections easily cleanable, located and protected
Amtrak Maintenance Facility	Food and Cosmetics	05/29/2024	Designed to permit ready cleaning
Amtrak Maintenance Facility	Food and Cosmetics	05/29/2024	Prevention of contamination
Arxium, Inc.	Devices	04/01/2024	Lack of or inadequate procedures
Arxium, Inc.	Devices	04/01/2024	Lack of or inadequate complaint procedures
Bajaj Medical, LLC	Drugs	12/04/2024	Failure to develop written procedures
Chemblend of America, LLC	Drugs	06/07/2024	Lack of quality control unit
Chemblend of America, LLC	Drugs	06/07/2024	Control procedures to monitor and validate performance
Chemblend of America, LLC	Drugs	06/07/2024	In-process conformity - examination, sample testing
Chemblend of America, LLC	Drugs	06/07/2024	Procedures for non-sterile drug products
Chemblend of America, LLC	Drugs	06/07/2024	Adequate number of batches on stability
Chicago Housewares, Inc.	Food and Cosmetics	02/26/2024	Personnel
Chicago Housewares, Inc.	Food and Cosmetics	02/26/2024	Sanitary operations - Plant sanitation
Chicago Indoor Garden, Inc.	Food and Cosmetics	09/24/2024	Records - equipment cleaning and sanitizing
Chicago Indoor Garden, Inc.	Food and Cosmetics	09/24/2024	Written environmental monitoring plan
Chicago Indoor Garden, Inc.	Food and Cosmetics	09/24/2024	Written sampling plan for spent irrigation water or sprouts
Coapt, LLC	Devices	10/28/2024	Lack of or inadequate procedures
Coapt, LLC	Devices	10/28/2024	Documentation
DO&Company Chicago Catering	Food and Cosmetics	11/29/2024	Plant construction and design
DO&Company Chicago Catering	Food and Cosmetics	11/29/2024	Sanitation preventive controls - Appropriate (Adequate)
Eco Food Distribution, LLC	Food and Cosmetics	02/07/2024	Develop FSVP
Essations, Inc.	Drugs	06/06/2024	Cleaning / Sanitizing / Maintenance
Essations, Inc.	Drugs	06/06/2024	Absence of Written Procedures
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Develop FSVP
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Hazard analysis biological, chemical, physical
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Document review entity's hazard analysis
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Supplier approval - document
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Revaluate - new information
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Unapproved supplier procedures - importer established
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Supplier verification - establish written procedures
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Verification activity assurance
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Verification activity before import, periodically
Euphrates Food, LLC	Food and Cosmetics	04/04/2024	Record - available
Eversight Illinois	Biologics	06/18/2024	Deviations--evaluation, cause, corrective action
Eversight Illinois	Biologics	06/18/2024	Procedures to meet core CTGP
Fish Fridge, LLC	Food and Cosmetics	08/06/2024	Importer verification
Five Star Trading IL, Inc.	Food and Cosmetics	06/14/2024	Develop FSVP
Five Star Trading IL, Inc.	Food and Cosmetics	06/14/2024	Hazard analysis biological, chemical, physical
Five Star Trading IL, Inc.	Food and Cosmetics	06/14/2024	Document review entity's hazard analysis
Five Star Trading IL, Inc.	Food and Cosmetics	06/14/2024	Approved supplier procedures - importer established
Five Star Trading IL, Inc.	Food and Cosmetics	06/14/2024	Supplier verification - establish written procedures
Five Star Trading IL, Inc.	Food and Cosmetics	06/14/2024	Verification activity assurance
Five Star Trading IL, Inc.	Food and Cosmetics	06/14/2024	Verification activity before import, periodically
Five Star Trading IL, Inc.	Food and Cosmetics	06/14/2024	Identification - entry
Fresh Express Incorporated	Food and Cosmetics	07/19/2024	Personnel
Fresh Express Incorporated	Food and Cosmetics	07/19/2024	Equipment and utensils - Design and maintenance
Fresh Express Incorporated	Food and Cosmetics	07/19/2024	Storage and Distribution
Fresh Express Incorporated	Food and Cosmetics	07/19/2024	Sanitation preventive controls - Implement
GE Healthcare, Inc.	Drugs	03/08/2024	Ensuring compliance with plan and protocol
Great Wall Seafood, LLC	Food and Cosmetics	08/09/2024	Importer verification
IKEA Food Supply, Inc.	Food and Cosmetics	02/05/2024	Develop FSVP
IKEA Food Supply, Inc.	Food and Cosmetics	02/05/2024	Identification - entry
IKEA Food Supply, Inc.	Veterinary	02/05/2024	Develop FSVP
IKEA Food Supply, Inc.	Veterinary	02/05/2024	Identification - entry
Jeron Electronic Systems, Inc.	Devices	12/04/2024	Documentation
Keurig Dr Pepper	Food and Cosmetics	02/01/2024	Personnel
Keurig Dr Pepper	Food and Cosmetics	02/01/2024	Sanitary operations - Plant sanitation
Keurig Dr Pepper	Food and Cosmetics	02/01/2024	Pest control
Keurig Dr Pepper	Food and Cosmetics	02/01/2024	Sanitation of non-food-contact surfaces - Manner and frequency
Keurig Dr Pepper	Food and Cosmetics	02/01/2024	Appropriate quality control operations
Keurig Dr Pepper	Food and Cosmetics	02/01/2024	Other preventive controls - Implement
Key Foods Company	Food and Cosmetics	04/25/2024	Develop FSVP
Linde Gas & Equipment, Inc.	Drugs	09/19/2024	Computer control of master formula records
Linde Gas & Equipment, Inc.	Drugs	09/19/2024	Calibration - at intervals, written program, remedial action
Loyola University Medical Center	Biologics	12/05/2024	Maintenance - concurrence
Loyola University Medical Center	Biologics	12/05/2024	Establish, maintain and follow manufacturing SOPs
Luster Products, Inc.	Drugs	09/13/2024	Procedures not in writing, fully followed
Luster Products, Inc.	Drugs	09/13/2024	Training--operations, GMPs, written procedures
Luster Products, Inc.	Drugs	09/13/2024	Component identification test
Luster Products, Inc.	Drugs	09/13/2024	Drug products-sampling procedures/specifications
Luster Products, Inc.	Drugs	09/13/2024	Lack of written stability program
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Individual Report of Malfunction
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Design changes - Lack of or Inadequate Procedures
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Purchasing controls, Lack of or inadequate procedures
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Lack of or inadequate procedures
MEDLINE INDUSTRIES, LP - Northfield	Devices	01/22/2024	Lack of or inadequate complaint procedures
Mars Foods US	Food and Cosmetics	01/11/2024	Identification - entry
Peninsula Chicago, LLC	Food and Cosmetics	07/09/2024	Develop FSVP
RNA Corporation	Drugs	03/08/2024	Procedures not in writing, fully followed
RNA Corporation	Drugs	03/08/2024	Buildings of Suitable Size, Construction, Location
RNA Corporation	Drugs	03/08/2024	Computer control of master formula records
RNA Corporation	Drugs	03/08/2024	Procedures for non-sterile drug products
Regal Health Food International, Inc.	Food and Cosmetics	09/05/2024	Hazard analysis - Identification of hazard
SSF Food Distribution, Inc.	Food and Cosmetics	03/18/2024	Develop FSVP
SSF Food Distribution, Inc.	Food and Cosmetics	03/18/2024	Very small importer assurances, supplier
Sterigenics International, LLC	Devices	12/17/2024	Lack of or inadequate procedures
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Hazard analysis biological, chemical, physical
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Document review entity's hazard analysis
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Approved supplier procedures - importer established
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Supplier verification - establish written procedures
VHRK Food, Inc.	Food and Cosmetics	03/27/2024	Verification activity assurance
Vee Pak, LLC	Drugs	12/10/2024	Scientifically sound laboratory controls
Vee Pak, LLC	Drugs	12/10/2024	Written record of investigation incomplete