FDA 483 - Advanced Vascular Dynamics - April 18, 2016

Ventor Technologies, Inc., a medical device manufacturer in Milwaukie, OR, was cited for three observations during an FDA inspection. The firm failed to adequately establish procedures for finished device acceptance, including sterilization process criteria and quarantine times. Additionally, the company did not properly investigate complaints involving device failures and lacked adequate procedures for receiving, reviewing, and evaluating complaints.