FDA 483 - Tonica Elektronik A/S - December 07, 2017

Tonica Elektronik A/S, a medical device manufacturer in Farum, Denmark, was cited for significant deficiencies in its quality system during an FDA inspection. The observations primarily concern inadequate procedures and investigations related to complaint handling, design control, quality data analysis, and rework of nonconforming products. These issues indicate a lack of robust controls to ensure device quality and patient safety.