North Cook News

There were 66 companies in cities associated with Cook County that received FDA citations as a result of 69 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 7% decrease from the number of companies cited in the previous year.

Of the 180 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 the Devices sector.

Of the companies cited, 62 should take voluntary actions to correct their managing operations (93.9%). Additionally, five companies had to take regulatory and/or administrative actions (7.6%).

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
A. B. Company, Inc.	Food and Cosmetics	05/18/2023	Develop FSVP
ABC Cork Company	Food and Cosmetics	01/31/2023	Evaluation - performance, risk
ABC Cork Company	Food and Cosmetics	01/31/2023	Supplier approval - document
Abbott Molecular, Inc.	Devices	01/27/2023	Lack of or inadequate procedures
Abbott Molecular, Inc.	Devices	01/27/2023	Documentation
Aherb USA, Inc.	Food and Cosmetics	03/31/2023	Supplier approval - document
Aman Kapoor In	Food and Cosmetics	08/24/2023	Develop FSVP
Amtrak	Food and Cosmetics	07/21/2023	Maintained in clean condition
Amtrak	Food and Cosmetics	07/21/2023	Clean and free of flies and mosquitoes
Amtrak	Food and Cosmetics	07/21/2023	Prevention of contamination
Amtrak	Food and Cosmetics	07/21/2023	Adequate and readily accessible
Amtrak - CUS - Wolverine #350 - 355 Train	Food and Cosmetics	07/21/2023	Maintained in good repair
Amtrak - CUS - Wolverine #350 - 355 Train	Food and Cosmetics	07/21/2023	Maintained in clean condition
Amtrak - CUS - Wolverine #350 - 355 Train	Food and Cosmetics	07/21/2023	Clean and free of flies and mosquitoes
Anglo Freight USA, Inc.	Food and Cosmetics	07/14/2023	Develop FSVP
Avlon Industries, Inc.	Drugs	01/24/2023	Procedures not in writing, fully followed
Avlon Industries, Inc.	Drugs	01/24/2023	Equipment Design, Size and Location
Avlon Industries, Inc.	Drugs	01/24/2023	Written procedures not established/followed
Avlon Industries, Inc.	Drugs	01/24/2023	Identity Testing of Each Component
Avlon Industries, Inc.	Drugs	01/24/2023	Absence of Written Procedures
Avlon Industries, Inc.	Drugs	01/24/2023	Scientifically sound laboratory controls
Avlon Industries, Inc.	Drugs	01/24/2023	Sample size - test intervals
Avlon Industries, Inc.	Drugs	01/24/2023	Written records kept in individual logs
Ayn Claire, LLC	Food and Cosmetics	09/11/2023	Develop FSVP
BN Trading, Inc.	Food and Cosmetics	05/26/2023	Develop FSVP
Babylon, Inc.	Food and Cosmetics	03/06/2023	LACF regulations
Babylon, Inc.	Food and Cosmetics	03/06/2023	Very small importer assurances, supplier
Blommer Chocolate Company, Inc.	Food and Cosmetics	09/29/2023	Plant construction and design
Blommer Chocolate Company, Inc.	Food and Cosmetics	09/29/2023	Plant operations - Precautions
Blommer Chocolate Company, Inc.	Food and Cosmetics	09/29/2023	Manufacturing, processing, packing, holding - Controls
Bozic'S Imports & Wholesale Liquors	Food and Cosmetics	07/19/2023	Develop FSVP
Bridge to Life, Ltd.	Devices	09/21/2023	Management review - Lack of or inadequate procedures
Bridge to Life, Ltd.	Devices	09/21/2023	Quality Audit/Reaudit - conducted
Bridge to Life, Ltd.	Devices	09/21/2023	Investigation of device failures
CFC, Inc.	Food and Cosmetics	04/28/2023	Process filing
CSL Plasma, Inc.	Biologics	03/29/2023	Adverse Reaction- Reports of Investigations
Cheshni Foods, LLC	Food and Cosmetics	04/28/2023	Develop FSVP
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
Chicago Food Corporation	Food and Cosmetics	08/16/2023	Develop FSVP
Chicago Food Corporation	Food and Cosmetics	08/16/2023	Hazard analysis biological, chemical, physical
Chicago Food Corporation	Food and Cosmetics	08/16/2023	Approved supplier procedures - importer established
Chicago Food Corporation	Food and Cosmetics	08/16/2023	Supplier verification - establish written procedures
Chicago Food Corporation	Food and Cosmetics	08/16/2023	Verification activity - appropriate
Conagra Brands, Inc.	Food and Cosmetics	11/22/2023	Identification - entry
Conagra Brands, Inc.	Food and Cosmetics	03/02/2023	Supplier approval - document
Conagra Brands, Inc.	Food and Cosmetics	03/02/2023	Verification activity before import, periodically
Cremeria Santa Maria	Food and Cosmetics	05/15/2023	Evaluation - performance, risk
Cremeria Santa Maria	Food and Cosmetics	05/15/2023	Supplier approval - document
Cremeria Santa Maria	Food and Cosmetics	05/15/2023	Approved supplier procedures - importer established
Cremeria Santa Maria	Food and Cosmetics	05/15/2023	Supplier verification - establish written procedures
Cremeria Santa Maria	Food and Cosmetics	05/15/2023	Verification activity assurance
Cremeria Santa Maria	Food and Cosmetics	05/15/2023	Verification activity frequency
Cremeria Santa Maria	Food and Cosmetics	05/15/2023	Verification activity - appropriate
Cremeria Santa Maria	Food and Cosmetics	05/15/2023	Verification activity before import, periodically
Cremeria Santa Maria	Food and Cosmetics	05/15/2023	Record - available
Eco Food Distribution, LLC	Food and Cosmetics	03/29/2023	Develop FSVP
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
FiMex, Inc.	Food and Cosmetics	05/12/2023	Hazard analysis biological, chemical, physical
FiMex, Inc.	Food and Cosmetics	05/12/2023	Evaluation - performance, risk
FiMex, Inc.	Food and Cosmetics	05/12/2023	Supplier approval - document
FiMex, Inc.	Food and Cosmetics	05/12/2023	Approved supplier procedures - importer established
FiMex, Inc.	Food and Cosmetics	05/12/2023	Supplier verification - establish written procedures
Five Star Trading IL, Inc.	Food and Cosmetics	08/31/2023	Develop FSVP
Five Star Trading IL, Inc.	Food and Cosmetics	08/31/2023	Revaluate - new information
Five Star Trading IL, Inc.	Food and Cosmetics	08/31/2023	Reevaluate - 3 years
Five Star Trading IL, Inc.	Food and Cosmetics	08/31/2023	Approved supplier procedures - follow, document use
Five Star Trading IL, Inc.	Food and Cosmetics	08/31/2023	Unapproved supplier procedures - importer established
Five Star Trading IL, Inc.	Food and Cosmetics	08/31/2023	Verification activity - appropriate
Five Star Trading IL, Inc.	Food and Cosmetics	08/31/2023	Verification activity before import, periodically
Five Star Trading IL, Inc.	Food and Cosmetics	08/31/2023	Modify FSVP
Five Star Trading IL, Inc.	Food and Cosmetics	08/31/2023	Identification - entry
Fresenius Kabi USA, LLC	Drugs	08/24/2023	Procedures not in writing, fully followed
Grafton Medical Alliance	Devices	10/26/2023	Lack of or inadequate procedures
Grafton Medical Alliance	Devices	10/26/2023	Complaints
Halal Healthy List, Inc.	Food and Cosmetics	07/14/2023	Develop FSVP
Harvester Foods, Corp.	Food and Cosmetics	02/23/2023	Sanitary operations - Plant maintenance
Harvester Foods, Corp.	Food and Cosmetics	02/23/2023	Equipment and utensils - Design and maintenance
Harvester Foods, Corp.	Food and Cosmetics	02/23/2023	Storage and Distribution
Harvester Foods, Corp.	Food and Cosmetics	02/23/2023	Hazard analysis - Identification of hazard
Harvester Foods, Corp.	Food and Cosmetics	02/23/2023	Process preventive controls - Implement
Harvester Foods, Corp.	Food and Cosmetics	02/23/2023	PCQI training records
Immersivetouch, Inc.	Devices	09/14/2023	Quality Audit/Reaudit - conducted
Immersivetouch, Inc.	Devices	09/14/2023	Design changes - Lack of or Inadequate Procedures
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
Inventex Medical	Devices	09/13/2023	Training - Lack of or inadequate procedures
Inventus Power, Inc.	Devices	03/28/2023	Lack of or inadequate procedures
Inventus Power, Inc.	Devices	03/28/2023	Documentation
J & B Distributing Company	Food and Cosmetics	09/07/2023	Very small importer assurances, supplier
J. Carlos, Inc.	Food and Cosmetics	02/14/2023	Hazard analysis written
J. Carlos, Inc.	Food and Cosmetics	02/14/2023	Evaluation - performance, risk
J. Carlos, Inc.	Food and Cosmetics	02/14/2023	Record - translate to English
JLS Foods International	Food and Cosmetics	08/31/2023	Hazard analysis written
JLS Foods International	Food and Cosmetics	08/31/2023	Approved supplier procedures - importer established
Jerez Produce, Inc.	Food and Cosmetics	02/28/2023	Develop FSVP
Los Rodriguez Prod and Supplies, Inc.	Food and Cosmetics	08/15/2023	Develop FSVP
Luminex Corporation	Devices	01/20/2023	Lack of Written MDR Procedures
MIE America, Inc.	Devices	09/14/2023	Management ensuring quality policy is understood
MIE America, Inc.	Devices	09/14/2023	Quality audits - Lack of or inadequate procedures
MIE America, Inc.	Devices	09/14/2023	Lack of or inadequate procedures
Mak-System Corporation	Biologics	08/11/2023	Lack of or inadequate procedures
Mak-System Corporation	Biologics	08/11/2023	Documentation
Mak-System Corporation	Biologics	08/11/2023	Lack of or inadequate complaint procedures
Mak-System Corporation	Devices	08/11/2023	Lack of or inadequate procedures
Mak-System Corporation	Devices	08/11/2023	Documentation
Mak-System Corporation	Devices	08/11/2023	Lack of or inadequate complaint procedures
Michael Lewis Company, Inc.	Food and Cosmetics	08/23/2023	Develop FSVP
Musk & Oud, Inc.	Food and Cosmetics	08/22/2023	Very small importer assurances, supplier
New Chicago Wholesale, Inc.	Food and Cosmetics	06/14/2023	Equipment and utensils - Design and maintenance
New Chicago Wholesale, Inc.	Food and Cosmetics	06/14/2023	Raw materials - Allergen identification
Old World Quality Foods, LLC	Food and Cosmetics	04/14/2023	Develop FSVP
Old World Quality Foods, LLC	Food and Cosmetics	04/14/2023	Hazard analysis biological, chemical, physical
Old World Quality Foods, LLC	Food and Cosmetics	04/14/2023	Supplier verification - establish written procedures
Old World Quality Foods, LLC	Food and Cosmetics	04/14/2023	Identification - entry
Olybio Foods Best of Nature, Inc.	Food and Cosmetics	06/06/2023	Develop FSVP
Olybio Foods Best of Nature, Inc.	Food and Cosmetics	06/06/2023	Hazard analysis written
Olybio Foods Best of Nature, Inc.	Food and Cosmetics	06/06/2023	Evaluation - performance, risk
Olybio Foods Best of Nature, Inc.	Food and Cosmetics	06/06/2023	Supplier approval - document
Olybio Foods Best of Nature, Inc.	Food and Cosmetics	06/06/2023	Approved supplier procedures - importer established
Olybio Foods Best of Nature, Inc.	Food and Cosmetics	06/06/2023	Verification activity assurance
Pal Global Imports	Food and Cosmetics	07/11/2023	Very small importer assurances, supplier
Parul, Inc.	Food and Cosmetics	03/22/2023	Develop FSVP
Pastorelli Food Products, Inc.	Food and Cosmetics	02/23/2023	Hazard analysis written
Pastorelli Food Products, Inc.	Food and Cosmetics	02/23/2023	Evaluation - performance, risk
Pastorelli Food Products, Inc.	Food and Cosmetics	02/23/2023	Approved supplier procedures - importer established
Pastorelli Food Products, Inc.	Food and Cosmetics	02/23/2023	Supplier verification - establish written procedures
Pastorelli Food Products, Inc.	Food and Cosmetics	02/23/2023	Verification activity frequency
Phoenicia Trading, Inc.	Food and Cosmetics	02/14/2023	Develop FSVP
Phoenicia Trading, Inc.	Food and Cosmetics	02/14/2023	Supplier approval - document
Phoenicia Trading, Inc.	Food and Cosmetics	02/14/2023	Approved supplier procedures - importer established
Phoenicia Trading, Inc.	Food and Cosmetics	02/14/2023	Verification activity assurance
Phoenicia Trading, Inc.	Food and Cosmetics	02/14/2023	Verification activity before import, periodically
Polish Folklore Import Company, Inc.	Food and Cosmetics	05/15/2023	Document review entity's hazard analysis
Polish Folklore Import Company, Inc.	Food and Cosmetics	05/15/2023	Supplier approval - document
Polish Folklore Import Company, Inc.	Food and Cosmetics	05/15/2023	Approved supplier procedures - importer established
Polish Folklore Import Company, Inc.	Food and Cosmetics	05/15/2023	Record - sign, date
Raul Romero Services, Inc.	Food and Cosmetics	06/14/2023	Develop FSVP
Reliance Service	Food and Cosmetics	04/03/2023	Develop FSVP
Sands Impex, Inc.	Food and Cosmetics	06/26/2023	Develop FSVP
Sunstar Americas, Inc.	Devices	02/10/2023	Lack of or inadequate procedures
TB Spices and Dry Peppers, LLC	Food and Cosmetics	09/27/2023	Supplier verification - establish written procedures
TB Spices and Dry Peppers, LLC	Food and Cosmetics	09/27/2023	Verification activity before import, periodically
TB Spices and Dry Peppers, LLC	Food and Cosmetics	09/27/2023	Audit - food safety regulation, plan
Tricor Systems	Devices	03/08/2023	Lack of Written MDR Procedures
Tricor Systems	Devices	03/08/2023	Training - Lack of or inadequate procedures
Tricor Systems	Devices	03/08/2023	Supplier oversight
Tricor Systems	Devices	03/08/2023	Servicing - Lack of or inadequate procedures
Uberlube, Inc.	Devices	02/16/2023	Records not kept
Uberlube, Inc.	Devices	02/16/2023	Design Validation - Risk analysis not performed/inadequate
Uberlube, Inc.	Devices	02/16/2023	Maintenance schedule, Lack of or inadequate schedule
Uberlube, Inc.	Devices	02/16/2023	Lack of or inadequate process validation
Uberlube, Inc.	Devices	02/16/2023	Lack of or inadequate procedures - Acceptance activities
Uberlube, Inc.	Devices	02/16/2023	Nonconforming product, Lack of or inadequate procedures
Uberlube, Inc.	Devices	02/16/2023	Lack of or inadequate procedures
Uberlube, Inc.	Devices	02/16/2023	Lack of or inadequate DHR procedures
Uberlube, Inc.	Devices	02/16/2023	Lack of or inadequate complaint procedures
VHRK Food, Inc.	Food and Cosmetics	07/18/2023	Develop FSVP
VHRK Food, Inc.	Food and Cosmetics	07/18/2023	Hazard analysis written
VHRK Food, Inc.	Food and Cosmetics	07/18/2023	Evaluation - performance, risk
VHRK Food, Inc.	Food and Cosmetics	07/18/2023	Supplier approval - document
VHRK Food, Inc.	Food and Cosmetics	07/18/2023	Approved supplier procedures - importer established
VHRK Food, Inc.	Food and Cosmetics	07/18/2023	Verification activity assurance
VHRK Food, Inc.	Food and Cosmetics	07/18/2023	Verification activity before import, periodically
Vee Pak, LLC	Drugs	12/11/2023	Valid stability test methods
Viola Imports, Inc.	Food and Cosmetics	06/08/2023	Develop FSVP
World's Finest Chocolate	Food and Cosmetics	02/02/2023	Sanitary operations - Plant maintenance
Yafa, Inc.	Food and Cosmetics	06/02/2023	Very small importer assurances, supplier
Yms, LLC	Food and Cosmetics	03/06/2023	Sanitary operations - Plant maintenance
ZB Importing, LLC	Food and Cosmetics	04/24/2023	Food safety plan