FDA 483 - Dottikon Exclusive Synthesis AG

During an inspection from December 12-16, 2022, the FDA observed Dottikon Exclusive Synthesis AG, an intermediate and API manufacturer in Dottikon, Switzerland, failed to follow its written procedures. Specifically, the firm did not inform Quality Management about overdue scheduled maintenance for 24 vessels and failed to properly sample and analyze a critical material used in manufacturing processes. These deficiencies indicate a lack of adherence to established quality control protocols.