FDA 483 - Noras MRT Products GmbH - May 17, 2018

An FDA inspection of Noras MRT Products GmbH in Hochberg, Germany, revealed four significant quality system deficiencies. The firm failed to adequately review and revalidate processes after changes, maintain device master records, conduct proper risk analysis, and ensure device history records align with master records. These issues indicate a lack of robust quality control in medical device manufacturing.