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

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.