Dupage Policy Journal

There were 50 companies in cities associated with DuPage County that received FDA citations as a result of 52 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 3.8% decrease from the number of companies cited in the previous year.

Of the 158 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, 48 should take voluntary actions to correct their managing operations (96%). Additionally, two companies had to take regulatory and/or administrative actions (4%).

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
ABC Cork Company	Food and Cosmetics	01/31/2023	Evaluation - performance, risk
ABC Cork Company	Food and Cosmetics	01/31/2023	Supplier approval - document
All American Nut & Candy	Food and Cosmetics	06/29/2023	Hazard analysis written
All American Nut & Candy	Food and Cosmetics	06/29/2023	Document review entity's hazard analysis
All American Nut & Candy	Food and Cosmetics	06/29/2023	Approved supplier procedures - follow, document use
All American Nut & Candy	Food and Cosmetics	06/29/2023	Record - sign, date
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
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
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
Cugini Distrubution, LLC	Food and Cosmetics	02/01/2023	Develop FSVP
Cugini Distrubution, LLC	Food and Cosmetics	02/01/2023	Hazard analysis written
Cugini Distrubution, LLC	Food and Cosmetics	02/01/2023	Evaluation - performance, risk
Cugini Distrubution, LLC	Food and Cosmetics	02/01/2023	Approved supplier procedures - importer established
Cugini Distrubution, LLC	Food and Cosmetics	02/01/2023	Supplier verification - establish written procedures
Cugini Distrubution, LLC	Food and Cosmetics	02/01/2023	Verification activity assurance
Cugini Distrubution, LLC	Food and Cosmetics	02/01/2023	Verification activity frequency
Cugini Distrubution, LLC	Food and Cosmetics	02/01/2023	Verification activity before import, periodically
Elmed Incorporated	Devices	07/17/2023	Individual Report of Malfunction
Elmed Incorporated	Devices	07/17/2023	Lack of or inadequate procedures - Acceptance activities
Elmed Incorporated	Devices	07/17/2023	Lack of or inadequate DHR procedures
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
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Supplier approval - document
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Approved supplier procedures - importer established
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Supplier verification - establish written procedures
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Verification activity frequency
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Verification activity assurance
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Verification activity before import, periodically
Fresh Bubble Tea, LLC.	Food and Cosmetics	03/31/2023	Record - translate to English
Grafton Medical Alliance	Devices	10/26/2023	Lack of or inadequate procedures
Grafton Medical Alliance	Devices	10/26/2023	Complaints
Grante Foods International	Food and Cosmetics	07/11/2023	Develop FSVP
Grante Foods International	Food and Cosmetics	07/11/2023	Hazard analysis biological, chemical, physical
Grante Foods International	Food and Cosmetics	07/11/2023	Supplier approval - document
Grante Foods International	Food and Cosmetics	07/11/2023	Approved supplier procedures - importer established
Grante Foods International	Food and Cosmetics	07/11/2023	Supplier verification - establish written procedures
Grante Foods International	Food and Cosmetics	07/11/2023	Supplier verification assurance
Grante Foods International	Food and Cosmetics	07/11/2023	Verification activity assurance
Grante Foods International	Food and Cosmetics	07/11/2023	Verification activity frequency
Grante Foods International	Food and Cosmetics	07/11/2023	Verification activity before import, periodically
Grante Foods International	Food and Cosmetics	07/11/2023	Identification - entry
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
ITU Grocers, Inc.	Food and Cosmetics	01/20/2023	Develop FSVP
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
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
JuiceRx Cleanse, LLC	Food and Cosmetics	05/09/2023	Equipment and utensils - Design and maintenance
Krak Distributing, Inc.	Food and Cosmetics	06/08/2023	Develop FSVP
Krak Distributing, Inc.	Food and Cosmetics	06/08/2023	Hazard analysis biological, chemical, physical
Krak Distributing, Inc.	Food and Cosmetics	06/08/2023	Evaluation - performance, risk
Krak Distributing, Inc.	Food and Cosmetics	06/08/2023	Approved supplier procedures - importer established
Krak Distributing, Inc.	Food and Cosmetics	06/08/2023	Verification activity assurance
Los Rodriguez Prod and Supplies, Inc.	Food and Cosmetics	08/15/2023	Develop FSVP
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
Markpol Distributors, Inc.	Food and Cosmetics	09/13/2023	Good compliance standing
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
New Royal Distributors	Food and Cosmetics	05/12/2023	Develop FSVP
New Royal Distributors	Food and Cosmetics	05/12/2023	Hazard analysis written
New Royal Distributors	Food and Cosmetics	05/12/2023	Hazard analysis biological, chemical, physical
New Royal Distributors	Food and Cosmetics	05/12/2023	Evaluation - performance, risk
New Royal Distributors	Food and Cosmetics	05/12/2023	Approved supplier procedures - importer established
New Royal Distributors	Food and Cosmetics	05/12/2023	Supplier verification - establish written procedures
New Royal Distributors	Food and Cosmetics	05/12/2023	Verification activity assurance
New Royal Distributors	Food and Cosmetics	05/12/2023	Verification activity frequency
New Royal Distributors	Food and Cosmetics	05/12/2023	Verification activity - appropriate
New Royal Distributors	Food and Cosmetics	05/12/2023	Verification activity before import, periodically
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
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
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
Randy Morris School, M.D.	Biologics	06/14/2023	Risk factors, clinical evidence
Raul Romero Services, Inc.	Food and Cosmetics	06/14/2023	Develop FSVP
Sands Impex, Inc.	Food and Cosmetics	06/26/2023	Develop FSVP
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
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
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
V & G Commerce, LLC	Food and Cosmetics	05/05/2023	Develop FSVP
V & G Commerce, LLC	Food and Cosmetics	05/05/2023	Hazard analysis written
V & G Commerce, LLC	Food and Cosmetics	05/05/2023	Approved supplier procedures - importer established
V & G Commerce, LLC	Food and Cosmetics	05/05/2023	Supplier verification - establish written 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
Viola Imports, Inc.	Food and Cosmetics	06/08/2023	Develop FSVP
Wise Plastics Technologies, Inc.	Devices	05/19/2023	Quality plan
Wise Plastics Technologies, Inc.	Devices	05/19/2023	Documentation of software validation
Wise Plastics Technologies, Inc.	Devices	05/19/2023	Lack of or inadequate procedures
World's Finest Chocolate	Food and Cosmetics	02/02/2023	Sanitary operations - Plant maintenance
Yms, LLC	Food and Cosmetics	03/06/2023	Sanitary operations - Plant maintenance