FDA 483 - Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. - November 21, 2024

Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. in Aprilia, Italy, was inspected by the FDA from November 18-21, 2024. The inspection revealed a significant issue regarding the timely submission of annual reports for approved drug products. This indicates a lapse in regulatory compliance concerning post-market reporting requirements.