FDA 483 - Atmos Medizintechnik Gmbh & Co. KG - January 26, 2023

An FDA inspection of Atmos Medizintechnik Gmbh & Co. KG, a medical device manufacturer in Lenzkirch, Germany, revealed a significant deficiency in their quality system. The firm failed to establish procedures for design control, encompassing critical elements such as design planning, input, output, review, verification, validation, transfer, and changes. This indicates a fundamental lack of control over the design and development process for their medical devices.