FDA 483 - B. Braun Aesculap Japan Co., Ltd. - April 10, 2014

An FDA inspection of B. BRAUN AESCULAP JAPAN CO., LTD. in Tochigi-Shi, Japan, from April 7-10, 2014, revealed a significant lapse in quality control. The firm failed to document equipment calibrations for a critical environmental monitoring device used in the manufacturing of epidural anesthesia needles, with the device reportedly not calibrated since January 2009. This indicates a potential risk to product quality and patient safety due to uncontrolled manufacturing conditions.