FDA 483 - Miltenyi Biotec Gmbh - May 29, 2015

An FDA inspection of Miltenyi Biotec Gmbh in Bergisch Gladbach, Germany, revealed significant deficiencies in their medical device reporting and complaint handling procedures. The firm failed to establish adequate systems for identifying reportable events, documenting complaints, and maintaining complete investigation records. These findings indicate a need for comprehensive corrective actions to ensure compliance with regulatory requirements.