483
Thera Test Laboratories, Inc.Thera Test Laboratories, Inc. – FDA 483, Apr 21, 2025
Record Details
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.
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ID · fcf6cec8-aad0-4cfc-ba1f-11d02750e8b7
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