FDA 483 - Siegfried Evionnaz SA - March 31, 2023

An FDA inspection of Siegfried Evionnaz SA, an API manufacturer in Evionnaz, Switzerland, revealed significant deficiencies across three observations. These included inadequately designed and maintained production equipment, failure to monitor API stability characteristics as per procedures, and poor maintenance of buildings used for manufacturing and raw material storage, leading to water damage. The findings indicate a moderate level of concern regarding the firm's adherence to good manufacturing practices.