FDA 483 - MTT GMBH - May 27, 2023

An FDA inspection of MEDICAL TARGETING TECHNOLOGIES GMBH in Barum, Germany, identified significant deficiencies in their medical device quality system. The firm failed to maintain a device master record, establish procedures for device history records, and adequately define responsibilities for the disposition of nonconforming products. These observations indicate a need for improved quality system controls to ensure regulatory compliance.