# FDA 483 - Thera Test Laboratories, Inc. - July 21, 2021

Source: https://www.globalkeysolutions.net/records/483/thera-test-laboratories-inc/a96d4a01-3022-4bdb-8f21-2208094b7fbd

> FDA 483 for Thera Test Laboratories, Inc. on July 21, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Thera Test Laboratories, Inc.
- Inspection Date: 2021-07-21
- Product Type: device
- Office Name: Chicago District Office
- Summary: Thera Test Laboratories, Inc. in Lombard, IL, was inspected regarding its device manufacturing operations. The inspection revealed significant deficiencies in quality system documentation and reporting, including failure to report a device correction/removal, inadequate maintenance of device master and history records, and undocumented supplier evaluations. These issues indicate a lack of adherence to medical device quality system regulations.

## Related Documents

- [483 - 2025-04-21](https://www.globalkeysolutions.net/records/483/thera-test-laboratories-inc/fcf6cec8-aad0-4cfc-ba1f-11d02750e8b7)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

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