There were two companies in cities associated with DuPage County that received FDA citations as a result of two inspections conducted in the county in April, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous month.
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.
Both 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 |
|---|---|---|---|
| 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 |
