Mattioli Engineering Italia SpAAugust 30, 2018

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

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Record Details

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.

Company: Mattioli Engineering Italia SpA
Inspection Date: August 30, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Paul M. Kawamoto (issuing_officer)

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ID · e2a0656a-0efd-4974-86dd-dfdafd39d1fb