FDA 483 - Macromedics BV - August 09, 2018

Macromedics BV, a medical device manufacturer in Waddinxveen, Netherlands, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately document design history, establish robust CAPA and purchasing procedures, timely report medical device malfunctions, and properly manage complaints and nonconforming product rework. These issues indicate a systemic lack of adherence to quality system regulations.