FDA 483 - Mattioli Engineering Italia SpA - August 30, 2018

An FDA inspection of Mattioli Engineering Italia SpA, a medical device manufacturer in Calenzano, Italy, revealed two significant issues. The firm failed to adequately document design validation results for a Class 2 iontophoresis device and lacked written agreements with most suppliers and contractors for change notification. These findings indicate deficiencies in the firm's quality system.