FDA 483 - Tegra Medical Costa Rica Sa - July 04, 2025

The U.S. Food and Drug Administration (FDA) conducted an inspection of Tegra Medical Costa Rica Sa, an Active Pharmaceutical Ingredient (API) manufacturer, from June 30 to July 4, 2025. The inspection revealed significant deficiencies in the company's laboratory control system, indicating deviations from regulatory requirements for good manufacturing practices. Key issues centered on data integrity and document control. The visual inspection laboratory's computer systems lacked secure user access and audit trail capabilities. Critical visual inspection data was manually transcribed from unvalidated software to uncontrolled paper reports, hindering accurate data review. Furthermore, inspectors found shredded "Tegra Medical Data Collection/Inspection Reports" and "Final Inspection Reports" containing vital quality control data in both the visual inspection laboratory and packaging areas. These documents are essential for batch release and process validation. Tegra Medical is required to implement comprehensive corrective actions to address these observations, ensuring the integrity, security, and control of all laboratory data and records, including validating software, establishing robust user access, and maintaining complete and accurate documentation.