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

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.