FDA 483 - Ventec Life Systems, Inc. - December 17, 2025

An FDA inspection of Ventec Life Systems, Inc. in Bothell, WA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for timely complaint handling and processing. Additionally, device history records for the VOCSN Unified Respiratory System did not include or refer to primary identification labels, indicating a lack of adherence to manufacturing requirements.