FDA 483 - Ventec Life Systems, Inc. - July 27, 2022

Ventec Life Systems, Inc. in Bothell, WA, was inspected from July 14-27, 2022, revealing a significant regulatory non-compliance. The firm failed to submit Medical Device Reports (MDRs) within the required 30-day timeframe for malfunctions of its VOCSN Unified Respiratory System. These malfunctions were identified as being likely to cause or contribute to death or serious injury if they were to recur.