FDA: 41 companies in cities within DuPage County received 129 citations in 2025

Jim Traficant, Chief of Staff of FDA
Jim Traficant, Chief of Staff of FDA | https://www.fda.gov/
By A. S. Dejesus

There were 41 companies in cities associated with DuPage County that received FDA citations as a result of 41 inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).

This is a 36.7% increase over the number of companies cited in the previous year.

Of the 129 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 operated in the Devices sector.

All of the companies cited should take voluntary actions to correct their managing operations.

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 and quality.

Companies Located within DuPage County Cities and the Citations They Received in 2025
Company NameArea of BusinessInspection DateIssue Cited
ARCH Medical Solutions - ElmhurstDevices09/25/2025Lack of or inadequate process validation
ARCH Medical Solutions - ElmhurstDevices09/25/2025Nonconforming product, Lack of or inadequate procedures
Alpha Baking Company, Inc.Food and Cosmetics05/23/2025Plant construction and design
Alpha Baking Company, Inc.Food and Cosmetics05/23/2025Sanitary operations - Plant sanitation
Alpha Baking Company, Inc.Food and Cosmetics05/23/2025Pest control
Alpha Baking Company, Inc.Food and Cosmetics05/23/2025Equipment and utensils - Design and maintenance
Alpha Baking Company, Inc.Food and Cosmetics05/23/2025Process control - Foreign objects
Alpha Baking Company, Inc.Food and Cosmetics05/23/2025Human food by-products
Anglo Freight USA, Inc.Food and Cosmetics02/07/2025Not registered
Anglo Freight USA, Inc.Food and Cosmetics02/07/2025Identification - entry
Anglo Freight USA, Inc.Food and Cosmetics02/07/2025Very small importer assurances, supplier
Anglo Freight USA, Inc.Food and Cosmetics02/07/2025Record - sign, date
Aparna Kalyan, M.D.Drugs02/18/2025FD-1572, protocol compliance
Bajaj Medical, LLCDrugs08/25/2025Representative Samples Criteria
Blistex, Inc.Drugs05/01/2025Buildings not maintained in good state of repair
Cardinal Health, Inc.Drugs08/15/2025Master Production and Control Records
Cardinal Health, Inc.Drugs08/15/2025Lab sampling and test procedures
Chicago Food Market, Inc.Food and Cosmetics08/29/2025Identification - entry
Conexus Food SolutionsFood and Cosmetics02/06/2025Importer verification
Covemex, Corp.Food and Cosmetics06/11/2025Not registered
Covemex, Corp.Food and Cosmetics06/11/2025Develop FSVP
Covemex, Corp.Food and Cosmetics06/11/2025LACF compliance
Covemex, Corp.Food and Cosmetics06/11/2025Hazard analysis written
Covemex, Corp.Food and Cosmetics06/11/2025Evaluation - performance, risk
Covemex, Corp.Food and Cosmetics06/11/2025Approved supplier procedures - importer established
Covemex, Corp.Food and Cosmetics06/11/2025Supplier verification - establish written procedures
Covemex, Corp.Food and Cosmetics06/11/2025Verification activity assurance
Covemex, Corp.Food and Cosmetics06/11/2025Identification - entry
Dimension Inx, Corp.Devices02/27/2025Lack of or inadequate process validation
Dimension Inx, Corp.Devices02/27/2025Sampling methods - Lack of or inadequate procedures
Flying Food Group, LLCFood and Cosmetics01/30/2025Hazard analysis biological, chemical, physical
Fresh Land ImportsFood and Cosmetics07/08/2025Develop FSVP
Frontida Biopharm, LLCDrugs10/24/2025Lack of quality control unit
Frontida Biopharm, LLCDrugs10/24/2025Procedures not in writing, fully followed
Frontida Biopharm, LLCDrugs10/24/2025SOPs not followed / documented
Frontida Biopharm, LLCDrugs10/24/2025Control procedures to monitor and validate performance
Helget Gas Products, Inc.Drugs08/05/2025Written record of investigation incomplete
International Medsurg Connection, Inc.Devices10/17/2025Lack of System for Event Evaluations
JAB Produce, Inc.Food and Cosmetics06/10/2025Develop FSVP
JLS Foods InternationalFood and Cosmetics07/11/2025Develop FSVP
Korex Chicago, LLCDrugs02/07/2025Computer control of master formula records
Korex Chicago, LLCDrugs02/07/2025Control procedures to monitor and validate performance
Korex Chicago, LLCDrugs02/07/2025Procedures for non-sterile drug products
Korex Chicago, LLCDrugs02/07/2025Microbiological testing
Korex Chicago, LLCDrugs02/07/2025Valid stability test methods
Korex Chicago, LLCDrugs02/07/2025Investigations of discrepancies, failures
LBR Importing & Distributing, Inc.Food and Cosmetics08/29/2025Develop FSVP
Legend Enterprises, Inc.Food and Cosmetics09/17/2025Document review entity's hazard analysis
Legend Enterprises, Inc.Food and Cosmetics09/17/2025Evaluation - performance, risk
Legend Enterprises, Inc.Food and Cosmetics09/17/2025Reevaluate - 3 years
Legend Enterprises, Inc.Food and Cosmetics09/17/2025Approved supplier procedures - importer established
Legend Enterprises, Inc.Food and Cosmetics09/17/2025Unapproved supplier procedures - importer established
Legend Enterprises, Inc.Food and Cosmetics09/17/2025Verification activity frequency
Legend Enterprises, Inc.Food and Cosmetics09/17/2025Record - sign, date
Lightbody Medical Technologies, Inc.Biologics08/27/2025Evaluation--microorganisms, damage
Midway Vegetable Sales, LLCFood and Cosmetics06/04/2025Develop FSVP
Mondelez International, LLCFood and Cosmetics02/21/2025Sanitary operations - Plant maintenance
Mondelez International, LLCFood and Cosmetics02/21/2025Storage and Distribution
Mondelez International, LLCFood and Cosmetics02/21/2025Sanitation preventive controls - Appropriate (Adequate)
NOW Health Group, Inc.Food and Cosmetics09/12/2025Hygienic practices
NOW Health Group, Inc.Food and Cosmetics09/12/2025Equipment - design - appropriate and suitable
NOW Health Group, Inc.Food and Cosmetics09/12/2025Specifications - components
NOW Health Group, Inc.Food and Cosmetics09/12/2025Specifications - finished dietary supplement
NOW Health Group, Inc.Food and Cosmetics09/12/2025Appropriate tests, examinations; certificate of analysis
NOW Health Group, Inc.Food and Cosmetics09/12/2025Quality control production, process control; material review, disposition
NOW Health Group, Inc.Food and Cosmetics09/12/2025Master manufacturing record - record requirements
NOW Health Group, Inc.Food and Cosmetics09/12/2025Batch record - required information
NOW Health Group, Inc.Food and Cosmetics09/12/2025Standard reference materials; criteria for selecting
NOW Health Group, Inc.Food and Cosmetics09/12/2025Examination, testing; scientifically valid
Nelson Laboratories, LLCDrugs09/26/2025Procedures not in writing, fully followed
Nelson Laboratories, LLCDrugs09/26/2025input/output verification
Nelson Laboratories, LLCDrugs09/26/2025Test devices not meeting specifications
Nelson Laboratories, LLCDrugs09/26/2025Stability sample storage conditions described
Newly Weds Foods, LLCFood and Cosmetics08/15/2025Sanitary operations - Plant maintenance
Newly Weds Foods, LLCFood and Cosmetics08/15/2025Pest control
Newly Weds Foods, LLCFood and Cosmetics08/15/2025Sanitation of food-contact surfaces - Frequency
Newly Weds Foods, LLCFood and Cosmetics08/15/2025Sanitation preventive controls - Appropriate (Adequate)
Oberg Medical - XL DivisionDevices04/25/2025Lack of or inadequate complaint procedures
Paket CorporationDrugs04/10/2025Inadequate number of personnel
Paket CorporationDrugs04/10/2025Written procedures not established/followed
Phoenix Instruments, Inc.Devices05/30/2025Management ensuring quality policy is understood
Phoenix Instruments, Inc.Devices05/30/2025Documentation
Phoenix Instruments, Inc.Devices05/30/2025Lack of or inadequate complaint procedures
Physician Software Systems, LLCDevices04/17/2025Quality Audits - defined intervals
Prenosis, Inc.Devices11/19/2025Lack of Written MDR Procedures
Prenosis, Inc.Devices11/19/2025Quality plan
Prenosis, Inc.Devices11/19/2025Nonconforming product, Lack of or inadequate procedures
Retmap, Inc.Devices10/30/2025Management review - defined interval, sufficient frequency
Retmap, Inc.Devices10/30/2025Quality Audit/Reaudit - conducted
Retmap, Inc.Devices10/30/2025Acceptable supplier records, inadequate records
Retmap, Inc.Devices10/30/2025Equipment control activity documentation
Retmap, Inc.Devices10/30/2025Nonconforming product, Lack of or inadequate procedures
Retmap, Inc.Devices10/30/2025Lack of or inadequate procedures
Rush University System for Health IRBBiologics09/12/2025Confidentiality, FDA inspection of records
Rush University System for Health IRBDevices09/12/2025Confidentiality, FDA inspection of records
Rush University System for Health IRBDrugs09/12/2025Confidentiality, FDA inspection of records
Sequoia Dental Studio, LLCDevices05/21/2025Lack of Written MDR Procedures
Sequoia Dental Studio, LLCDevices05/21/2025Quality System Procedures
Sol-Millennium Medical, Inc.Devices05/08/2025Reporting Information Reasonably Known
Sol-Millennium Medical, Inc.Devices05/08/2025Device Available for Evaluation
Sol-Millennium Medical, Inc.Devices05/08/2025Submission of Supplement to Individual Report Within One Month
Sol-Millennium Medical, Inc.Devices05/08/2025Lack of or inadequate procedures
TJ Foods USA, LLCFood and Cosmetics03/19/2025Hazard analysis biological, chemical, physical
TJ Foods USA, LLCFood and Cosmetics03/19/2025Unapproved supplier procedures - importer established
TJ Foods USA, LLCFood and Cosmetics03/19/2025Verification activity frequency
TJ Foods USA, LLCFood and Cosmetics03/19/2025Identification - entry
The Advanced IVF Institute: Charles E. Miller & Associates, M.D.Biologics04/25/2025Statement re: certified testing lab
The Advanced IVF Institute: Charles E. Miller & Associates, M.D.Biologics04/25/2025Reasons for ineligibility on summary
The Advanced IVF Institute: Charles E. Miller & Associates, M.D.Biologics04/25/2025Documentation--determination, by whom, date
The Advanced IVF Institute: Charles E. Miller & Associates, M.D.Biologics04/25/2025Risk factors, clinical evidence
Thera Test Laboratories, Inc.Devices04/21/2025Quality policy and objectives
Thera Test Laboratories, Inc.Devices04/21/2025Lack of or inadequate organizational structure
Thera Test Laboratories, Inc.Devices04/21/2025Management review - Lack of or inadequate procedures
Thera Test Laboratories, Inc.Devices04/21/2025Lack of or inadequate procedures
Tortilleria Atotonilco, Inc.Food and Cosmetics10/23/2025Sanitary operations - Plant maintenance
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Written procedures - establish; personnel
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Written procedures - establish; cleaning
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Equipment - establish written procedures
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Specifications - labels, packaging
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Specifications - product received for packaging, labeling
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Reserve sample - collect, hold
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Written procedures - establish; quality control operations
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Written procedures - establish; components
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Master manufacturing record - prepared
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Batch record - every batch
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Written procedures - establish; packaging & labeling
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Written procedures - establish; holding and distribution
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Written procedures - establish; returned dietary supplements
Vital Hierbas Naturales CorporationFood and Cosmetics08/07/2025Written procedures - establish; product complaint
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.