Dupage Policy Journal

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

This is a 150% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• Quality audits were not performed at defined intervals to determine whether the quality system activities and results comply with quality system procedures.
• The quality policy was/were not established by management with executive responsibility.
• The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.

Most of the companies cited were involved in either Devices or Food and Cosmetics sectors.

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 quality.

Company Name	Area of Business	Inspection Date	Issue Cited
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
Midway Vegetable Sales, LLC	Food and Cosmetics	06/04/2025	Develop FSVP
Paket Corporation	Drugs	04/10/2025	Inadequate number of personnel
Paket Corporation	Drugs	04/10/2025	Written procedures not established/followed
Physician Software Systems, LLC	Devices	04/17/2025	Quality Audits - defined intervals
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