FDA EIR - B. BRAUN MELSUNGEN AG - February 15, 2018

An FDA inspection of B. Braun Melsungen AG, a German manufacturer of Class II medical devices, including infusion pumps and accessories, was conducted from February 12 to February 15, 2018. The inspection, guided by the FDA's medical device manufacturing regulations (21 CFR Part 800), covered key areas such as management controls, design controls, and corrective and preventive actions. Notably, the inspection concluded with no significant deficiencies observed, and no FDA-483 was issued. This indicates a positive compliance status for the company's operations. The report specifically highlighted that B. Braun Melsungen AG had successfully implemented adequate corrective actions to address all deficiencies identified during a previous FDA inspection conducted in March 2014. Therefore, no new violations or mandatory actions were required as a result of the 2018 assessment, reflecting the firm's adherence to regulatory standards for quality and safety.