FDA 483 - Aesculap AG - July 16, 2015

Aesculap AG, a device manufacturer in Tuttlingen, Germany, was inspected by the FDA from July 13-16, 2015. The inspection revealed a significant issue regarding the timely submission of Medical Device Reports (MDRs). Specifically, the firm failed to submit MDRs within 30 days for multiple complaints involving device malfunctions that could lead to death or serious injury if they recurred.