FDA 483 - Siesta Medical, Inc. - December 15, 2022

Siesta Medical, Inc. in Los Gatos, CA, was cited for significant deficiencies in its quality system related to its Encore System medical device. The inspection revealed failures in timely Medical Device Reporting, inadequate complaint handling procedures and investigations, insufficient design change controls, and incomplete risk analysis for identified device failure modes. These issues indicate a systemic breakdown in ensuring device safety and regulatory compliance.