FDA: 41 companies in cities within DuPage County received 129 citations in 2025
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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| ARCH Medical Solutions - Elmhurst | Devices | 09/25/2025 | Lack of or inadequate process validation |
| ARCH Medical Solutions - Elmhurst | Devices | 09/25/2025 | Nonconforming product, Lack of or inadequate procedures |
| Alpha Baking Company, Inc. | Food and Cosmetics | 05/23/2025 | Plant construction and design |
| Alpha Baking Company, Inc. | Food and Cosmetics | 05/23/2025 | Sanitary operations - Plant sanitation |
| Alpha Baking Company, Inc. | Food and Cosmetics | 05/23/2025 | Pest control |
| Alpha Baking Company, Inc. | Food and Cosmetics | 05/23/2025 | Equipment and utensils - Design and maintenance |
| Alpha Baking Company, Inc. | Food and Cosmetics | 05/23/2025 | Process control - Foreign objects |
| Alpha Baking Company, Inc. | Food and Cosmetics | 05/23/2025 | Human food by-products |
| Anglo Freight USA, Inc. | Food and Cosmetics | 02/07/2025 | Not registered |
| Anglo Freight USA, Inc. | Food and Cosmetics | 02/07/2025 | Identification - entry |
| Anglo Freight USA, Inc. | Food and Cosmetics | 02/07/2025 | Very small importer assurances, supplier |
| Anglo Freight USA, Inc. | Food and Cosmetics | 02/07/2025 | Record - sign, date |
| Aparna Kalyan, M.D. | Drugs | 02/18/2025 | FD-1572, protocol compliance |
| Bajaj Medical, LLC | Drugs | 08/25/2025 | Representative Samples Criteria |
| Blistex, Inc. | Drugs | 05/01/2025 | Buildings not maintained in good state of repair |
| Cardinal Health, Inc. | Drugs | 08/15/2025 | Master Production and Control Records |
| Cardinal Health, Inc. | Drugs | 08/15/2025 | Lab sampling and test procedures |
| Chicago Food Market, Inc. | Food and Cosmetics | 08/29/2025 | Identification - entry |
| Conexus Food Solutions | Food and Cosmetics | 02/06/2025 | Importer verification |
| Covemex, Corp. | Food and Cosmetics | 06/11/2025 | Not registered |
| Covemex, Corp. | Food and Cosmetics | 06/11/2025 | Develop FSVP |
| Covemex, Corp. | Food and Cosmetics | 06/11/2025 | LACF compliance |
| Covemex, Corp. | Food and Cosmetics | 06/11/2025 | Hazard analysis written |
| Covemex, Corp. | Food and Cosmetics | 06/11/2025 | Evaluation - performance, risk |
| Covemex, Corp. | Food and Cosmetics | 06/11/2025 | Approved supplier procedures - importer established |
| Covemex, Corp. | Food and Cosmetics | 06/11/2025 | Supplier verification - establish written procedures |
| Covemex, Corp. | Food and Cosmetics | 06/11/2025 | Verification activity assurance |
| Covemex, Corp. | Food and Cosmetics | 06/11/2025 | Identification - entry |
| Dimension Inx, Corp. | Devices | 02/27/2025 | Lack of or inadequate process validation |
| Dimension Inx, Corp. | Devices | 02/27/2025 | Sampling methods - Lack of or inadequate procedures |
| Flying Food Group, LLC | Food and Cosmetics | 01/30/2025 | Hazard analysis biological, chemical, physical |
| Fresh Land Imports | Food and Cosmetics | 07/08/2025 | Develop FSVP |
| Frontida Biopharm, LLC | Drugs | 10/24/2025 | Lack of quality control unit |
| Frontida Biopharm, LLC | Drugs | 10/24/2025 | Procedures not in writing, fully followed |
| Frontida Biopharm, LLC | Drugs | 10/24/2025 | SOPs not followed / documented |
| Frontida Biopharm, LLC | Drugs | 10/24/2025 | Control procedures to monitor and validate performance |
| Helget Gas Products, Inc. | Drugs | 08/05/2025 | Written record of investigation incomplete |
| International Medsurg Connection, Inc. | Devices | 10/17/2025 | Lack of System for Event Evaluations |
| JAB Produce, Inc. | Food and Cosmetics | 06/10/2025 | Develop FSVP |
| JLS Foods International | Food and Cosmetics | 07/11/2025 | Develop FSVP |
| Korex Chicago, LLC | Drugs | 02/07/2025 | Computer control of master formula records |
| Korex Chicago, LLC | Drugs | 02/07/2025 | Control procedures to monitor and validate performance |
| Korex Chicago, LLC | Drugs | 02/07/2025 | Procedures for non-sterile drug products |
| Korex Chicago, LLC | Drugs | 02/07/2025 | Microbiological testing |
| Korex Chicago, LLC | Drugs | 02/07/2025 | Valid stability test methods |
| Korex Chicago, LLC | Drugs | 02/07/2025 | Investigations of discrepancies, failures |
| LBR Importing & Distributing, Inc. | Food and Cosmetics | 08/29/2025 | Develop FSVP |
| Legend Enterprises, Inc. | Food and Cosmetics | 09/17/2025 | Document review entity's hazard analysis |
| Legend Enterprises, Inc. | Food and Cosmetics | 09/17/2025 | Evaluation - performance, risk |
| Legend Enterprises, Inc. | Food and Cosmetics | 09/17/2025 | Reevaluate - 3 years |
| Legend Enterprises, Inc. | Food and Cosmetics | 09/17/2025 | Approved supplier procedures - importer established |
| Legend Enterprises, Inc. | Food and Cosmetics | 09/17/2025 | Unapproved supplier procedures - importer established |
| Legend Enterprises, Inc. | Food and Cosmetics | 09/17/2025 | Verification activity frequency |
| Legend Enterprises, Inc. | Food and Cosmetics | 09/17/2025 | Record - sign, date |
| Lightbody Medical Technologies, Inc. | Biologics | 08/27/2025 | Evaluation--microorganisms, damage |
| Midway Vegetable Sales, LLC | Food and Cosmetics | 06/04/2025 | Develop FSVP |
| Mondelez International, LLC | Food and Cosmetics | 02/21/2025 | Sanitary operations - Plant maintenance |
| Mondelez International, LLC | Food and Cosmetics | 02/21/2025 | Storage and Distribution |
| Mondelez International, LLC | Food and Cosmetics | 02/21/2025 | Sanitation preventive controls - Appropriate (Adequate) |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Hygienic practices |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Equipment - design - appropriate and suitable |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Specifications - components |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Specifications - finished dietary supplement |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Appropriate tests, examinations; certificate of analysis |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Quality control production, process control; material review, disposition |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Master manufacturing record - record requirements |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Batch record - required information |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Standard reference materials; criteria for selecting |
| NOW Health Group, Inc. | Food and Cosmetics | 09/12/2025 | Examination, testing; scientifically valid |
| Nelson Laboratories, LLC | Drugs | 09/26/2025 | Procedures not in writing, fully followed |
| Nelson Laboratories, LLC | Drugs | 09/26/2025 | input/output verification |
| Nelson Laboratories, LLC | Drugs | 09/26/2025 | Test devices not meeting specifications |
| Nelson Laboratories, LLC | Drugs | 09/26/2025 | Stability sample storage conditions described |
| Newly Weds Foods, LLC | Food and Cosmetics | 08/15/2025 | Sanitary operations - Plant maintenance |
| Newly Weds Foods, LLC | Food and Cosmetics | 08/15/2025 | Pest control |
| Newly Weds Foods, LLC | Food and Cosmetics | 08/15/2025 | Sanitation of food-contact surfaces - Frequency |
| Newly Weds Foods, LLC | Food and Cosmetics | 08/15/2025 | Sanitation preventive controls - Appropriate (Adequate) |
| Oberg Medical - XL Division | Devices | 04/25/2025 | Lack of or inadequate complaint procedures |
| Paket Corporation | Drugs | 04/10/2025 | Inadequate number of personnel |
| Paket Corporation | Drugs | 04/10/2025 | Written procedures not established/followed |
| Phoenix Instruments, Inc. | Devices | 05/30/2025 | Management ensuring quality policy is understood |
| Phoenix Instruments, Inc. | Devices | 05/30/2025 | Documentation |
| Phoenix Instruments, Inc. | Devices | 05/30/2025 | Lack of or inadequate complaint procedures |
| Physician Software Systems, LLC | Devices | 04/17/2025 | Quality Audits - defined intervals |
| Prenosis, Inc. | Devices | 11/19/2025 | Lack of Written MDR Procedures |
| Prenosis, Inc. | Devices | 11/19/2025 | Quality plan |
| Prenosis, Inc. | Devices | 11/19/2025 | Nonconforming product, Lack of or inadequate procedures |
| Retmap, Inc. | Devices | 10/30/2025 | Management review - defined interval, sufficient frequency |
| Retmap, Inc. | Devices | 10/30/2025 | Quality Audit/Reaudit - conducted |
| Retmap, Inc. | Devices | 10/30/2025 | Acceptable supplier records, inadequate records |
| Retmap, Inc. | Devices | 10/30/2025 | Equipment control activity documentation |
| Retmap, Inc. | Devices | 10/30/2025 | Nonconforming product, Lack of or inadequate procedures |
| Retmap, Inc. | Devices | 10/30/2025 | Lack of or inadequate procedures |
| Rush University System for Health IRB | Biologics | 09/12/2025 | Confidentiality, FDA inspection of records |
| Rush University System for Health IRB | Devices | 09/12/2025 | Confidentiality, FDA inspection of records |
| Rush University System for Health IRB | Drugs | 09/12/2025 | Confidentiality, FDA inspection of records |
| Sequoia Dental Studio, LLC | Devices | 05/21/2025 | Lack of Written MDR Procedures |
| Sequoia Dental Studio, LLC | Devices | 05/21/2025 | Quality System Procedures |
| Sol-Millennium Medical, Inc. | Devices | 05/08/2025 | Reporting Information Reasonably Known |
| Sol-Millennium Medical, Inc. | Devices | 05/08/2025 | Device Available for Evaluation |
| Sol-Millennium Medical, Inc. | Devices | 05/08/2025 | Submission of Supplement to Individual Report Within One Month |
| Sol-Millennium Medical, Inc. | Devices | 05/08/2025 | Lack of or inadequate procedures |
| TJ Foods USA, LLC | Food and Cosmetics | 03/19/2025 | Hazard analysis biological, chemical, physical |
| TJ Foods USA, LLC | Food and Cosmetics | 03/19/2025 | Unapproved supplier procedures - importer established |
| TJ Foods USA, LLC | Food and Cosmetics | 03/19/2025 | Verification activity frequency |
| TJ Foods USA, LLC | Food and Cosmetics | 03/19/2025 | Identification - entry |
| The Advanced IVF Institute: Charles E. Miller & Associates, M.D. | Biologics | 04/25/2025 | Statement re: certified testing lab |
| The Advanced IVF Institute: Charles E. Miller & Associates, M.D. | Biologics | 04/25/2025 | Reasons for ineligibility on summary |
| The Advanced IVF Institute: Charles E. Miller & Associates, M.D. | Biologics | 04/25/2025 | Documentation--determination, by whom, date |
| The Advanced IVF Institute: Charles E. Miller & Associates, M.D. | Biologics | 04/25/2025 | Risk factors, clinical evidence |
| Thera Test Laboratories, Inc. | Devices | 04/21/2025 | Quality policy and objectives |
| Thera Test Laboratories, Inc. | Devices | 04/21/2025 | Lack of or inadequate organizational structure |
| Thera Test Laboratories, Inc. | Devices | 04/21/2025 | Management review - Lack of or inadequate procedures |
| Thera Test Laboratories, Inc. | Devices | 04/21/2025 | Lack of or inadequate procedures |
| Tortilleria Atotonilco, Inc. | Food and Cosmetics | 10/23/2025 | Sanitary operations - Plant maintenance |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Written procedures - establish; personnel |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Written procedures - establish; cleaning |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Equipment - establish written procedures |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Specifications - labels, packaging |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Specifications - product received for packaging, labeling |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Reserve sample - collect, hold |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Written procedures - establish; quality control operations |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Written procedures - establish; components |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Master manufacturing record - prepared |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Batch record - every batch |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Written procedures - establish; packaging & labeling |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Written procedures - establish; holding and distribution |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Written procedures - establish; returned dietary supplements |
| Vital Hierbas Naturales Corporation | Food and Cosmetics | 08/07/2025 | Written procedures - establish; product complaint |