Dupage Policy Journal

There were 24 companies in cities associated with DuPage County that received FDA citations as a result of 24 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 56.4% decrease from the number of companies cited in the previous year.

Of the 64 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 Devices sector.

Of the companies cited, 22 should take voluntary actions to correct their managing operations (91.7%). Additionally, two companies had to take regulatory and/or administrative actions (8.3%).

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
All American Nut & Candy, Corp.	Food and Cosmetics	09/23/2024	Hazard analysis written
All American Nut & Candy, Corp.	Food and Cosmetics	09/23/2024	Evaluation - performance, risk
All American Nut & Candy, Corp.	Food and Cosmetics	09/23/2024	Approved supplier procedures - follow, document use
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
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 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
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
Grante Foods International	Food and Cosmetics	11/01/2024	Identification - entry
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
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
Mars Foods US	Food and Cosmetics	01/11/2024	Identification - entry
Midwest Sperm Bank, LLC	Biologics	03/20/2024	Testing, screening, donor eligibility procedures
Midwest Sperm Bank, LLC	Biologics	03/20/2024	Determination based on screening and testing
NOW Health Group, Inc.	Food and Cosmetics	06/27/2024	Master manufacturing record - unique formulation
Peninsula Chicago, LLC	Food and Cosmetics	07/09/2024	Develop FSVP
Regal Health Food International, Inc.	Food and Cosmetics	09/05/2024	Hazard analysis - Identification of hazard
SpineCraft, LLC.	Devices	03/22/2024	Adverse events--all info not in file
SpineCraft, LLC.	Devices	03/22/2024	Complaints
Sterigenics International, LLC	Devices	12/17/2024	Lack of or inadequate procedures
Subco Foods, Inc.	Food and Cosmetics	08/19/2024	Registration
Subco Foods, Inc.	Food and Cosmetics	08/19/2024	Process filing
TLS America, Inc.	Food and Cosmetics	02/09/2024	Develop FSVP
TLS America, Inc.	Food and Cosmetics	02/09/2024	Document review entity's hazard analysis
TLS America, Inc.	Food and Cosmetics	02/09/2024	Supplier approval - document
TLS America, Inc.	Food and Cosmetics	02/09/2024	Approved supplier procedures - importer established
TLS America, Inc.	Food and Cosmetics	02/09/2024	Supplier verification - establish written procedures
TLS America, Inc.	Food and Cosmetics	02/09/2024	Verification activity assurance
TLS America, Inc.	Food and Cosmetics	02/09/2024	Verification activity frequency
U. S. Surgitech, Inc.	Devices	07/09/2024	Individual Report of Malfunction
U. S. Surgitech, Inc.	Devices	07/09/2024	Management review - defined interval, sufficient frequency
U. S. Surgitech, Inc.	Devices	07/09/2024	Quality Audits - defined intervals
U. S. Surgitech, Inc.	Devices	07/09/2024	Acceptable supplier records, inadequate records
U. S. Surgitech, Inc.	Devices	07/09/2024	Documentation
U. S. Surgitech, Inc.	Devices	07/09/2024	Complaints
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
Wenda Ingredients, LLC	Food and Cosmetics	01/12/2024	Document review entity's hazard analysis
Wenda Ingredients, LLC	Food and Cosmetics	01/12/2024	Supplier approval - document
Wenda Ingredients, LLC	Food and Cosmetics	01/12/2024	Approved supplier procedures - importer established