How many companies in cities across Cook County received FDA citations in 2024?

How many companies in cities across Cook County received FDA citations in 2024?
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA — Official Website
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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.

Companies Located Within Cook County Cities and the Citations They Received in 2024
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


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