FDA 483 - Karl Storz SE & Co. KG - March 12, 2020

An FDA inspection of Karl Storz SE & Co. KG, a medical device manufacturer in Tuttlingen, Germany, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for complaint handling, ensure service reports contained all required information, and control environmental conditions related to electrical energy. These issues indicate systemic problems in maintaining compliance with regulatory requirements.