FDA 483 - Cook Incorporated - June 04, 2025

Cook Incorporated in Bloomington, IN, was inspected regarding its medical device manufacturing operations and found to have significant deficiencies in its quality system. Observations included inadequate corrective and preventive action procedures, insufficient environmental controls for cleanrooms, unassessed equipment suitability for controlled environments, and poorly controlled or unvalidated production processes and test methods. These issues raise concerns about product conformity and potential patient impact.