FDA 483 - Viant Medical Company - September 26, 2025

Viant Medical, Inc., a contract manufacturer, underwent an FDA inspection from September 22-26, 2025, resulting in a Form FDA-483 outlining four significant observations regarding its quality system. The primary concerns revolved around inadequate corrective and preventive action (CAPA) procedures. Specifically, the firm's complaint handling system inappropriately assigned 'negligible' risk to 'not confirmed' complaints, preventing crucial root cause analysis even in cases involving serious outcomes such as patient death from device failure. Furthermore, the criteria for initiating CAPAs were found to be vague and lacked specificity. The inspection also identified deficiencies in complaint processing, noting an ambiguous probability/occurrence assessment table that impacted risk classification and subsequent CAPA determinations. Production process monitoring was deemed insufficient, with unaddressed out-of-specification cleanroom pressure readings and no established schedule for HEPA filter checks. Additionally, the company displayed systematic non-compliance with its own supplier re-assessment schedules, failing to conduct timely reviews for several medium and low-risk suppliers. These observations highlight the need for Viant Medical, Inc. to revise and effectively implement its procedures to comply with medical device quality system requirements. The firm has acknowledged these findings and committed to undertaking comprehensive corrective actions.