FDA 483 - iCE Neurosystems, Inc. - November 06, 2024

iCE Neurosystems, Inc. in Washington, DC, a medical device manufacturer, received a Form FDA-483 with four observations during an inspection. The firm failed to adequately establish and implement critical quality system procedures, including those for acceptance activities, software validation, management review, and internal audits. These deficiencies indicate significant issues within their quality management system.