FDA 483 - Atmos Medizintechnik Gmbh & Co. KG - September 16, 2022

Atmos Medizintechnik Gmbh & Co. KG, a medical device manufacturer in Lenzkirch, Germany, was cited with 25 observations during an FDA inspection. The inspection revealed a pervasive lack of established procedures across nearly all critical quality system elements, including design control, CAPA, complaint handling, training, and production controls. This indicates a fundamental deficiency in the firm's quality management system.