FDA 483 - Svelte Medical Systems, Inc. - June 14, 2021

Svelte Medical Systems in New Providence, NJ, was inspected and received a Form FDA 483 with five observations. The inspection revealed significant issues with design control documentation, including inadequately defined design outputs and insufficient documentation of design risk analysis results for their drug-eluting coronary stent system. Additionally, the firm's quality system procedures for corrective and preventive actions, management reviews, and device history records were found to be deficient.