FDA 483 - A3R, Llc - April 10, 2019

An FDA inspection of Visual Telecommunication Network, LLC dba Vitel Net in Mc Lean, VA, revealed significant deficiencies in their quality system. The firm failed to establish finished device acceptance procedures, adequately implement corrective and preventive actions, and document software validation activities. These issues indicate a lack of control over critical manufacturing and quality processes for medical devices.