FDA 483 - Avantec Vascular Corporation - January 10, 2020

Avantec Vascular Corporation in Sunnyvale, CA, a medical device manufacturer, received a Form 483 with three observations during an FDA inspection. The firm was cited for inadequate documentation of corrective and preventive actions for nonconforming material, failure to revalidate a manufacturing process after changes, and an insufficient risk analysis for its Captus Vascular Retrieval System. These findings indicate deficiencies in the company's quality system regarding CAPA, process control, and design control.