FDA 483 - Tegra Medical Costa Rica Sa - June 29, 2023

The FDA inspected Tegra Medical Costa Rica Sa, a contract manufacturer, from June 26-29, 2023. The inspection revealed that the firm's corrective and preventive action (CAPA) procedures were not adequately established. Specifically, the CAPA procedure failed to properly identify or reference the severity classification matrix used for assigning risk due dates.