# FDA 483 - Thera Test Laboratories, Inc. - April 21, 2025

Source: https://www.globalkeysolutions.net/records/483/thera-test-laboratories-inc/fcf6cec8-aad0-4cfc-ba1f-11d02750e8b7

> FDA 483 for Thera Test Laboratories, Inc. on April 21, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Thera Test Laboratories, Inc.
- Inspection Date: 2025-04-21
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Thera Test Laboratories, Inc., a medical device manufacturer in Lombard, IL, revealed significant deficiencies in their quality management system. Observations included inadequate procedures for corrective and preventive actions, a quality policy not established by executive management, and an organizational structure not adequately maintained. Additionally, the firm failed to include top management in a recent management review meeting.

## Related Documents

- [483 - 2021-07-21](https://www.globalkeysolutions.net/records/483/thera-test-laboratories-inc/a96d4a01-3022-4bdb-8f21-2208094b7fbd)

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/thera-test-laboratories-inc/a0444efd-ade8-4a1b-b2f9-6eb59e0fbccd

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669