FDA 483 - Lusomedicamenta Sociedade Tecnica Farmaceutica S.A - September 27, 2019

Lusomedicamenta Sociedade Tecnica Farmaceutica S.A. was inspected from September 23-27, 2019, and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality system controls, including issues with instrument calibration, raw material sampling, adherence to production procedures, change control management, and data backup and restoration. These findings indicate a need for improved procedural adherence and quality oversight.