Medtronic Puerto Rico Operations Co. – FDA 483, May 31, 2019

Medtronic Puerto Rico Operations Co. in Humacao, PR, was inspected and cited for significant deficiencies in its quality system, particularly concerning corrective and preventive actions, complaint investigations, nonconforming product control, and supplier quality management. The inspection revealed a pattern of inadequate investigations and controls related to component quality and device failures. These issues indicate a moderate level of severity in the firm's compliance with quality system requirements.