FDA 483 - sarmed srl - November 15, 2024

Sar-med srl, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to properly identify the acceptance status of medical devices, specifically labeling unsterilized products as "Sterile" without proper "Non-Sterile" identification. Additionally, personnel lacked adequate training and experience regarding USFDA regulations for medical device manufacturing and export.