FDA 483 - DRG Instruments GmbH - November 07, 2024

An FDA inspection of DRG Instruments GmbH, a medical device manufacturer in Marburg, Germany, revealed significant deficiencies in their quality system. Observations included inadequate corrective and preventive action procedures, undeveloped Medical Device Reporting (MDR) procedures, and incomplete complaint records. Additionally, the firm failed to provide required Unique Device Identifier (UDI) information to the Global UDI Database.