FDA 483 - BODY VISION MEDICAL - July 28, 2022

BODY VISION MEDICAL, an Israeli medical device manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. The firm's procedures for medical device reporting, complaint handling, servicing, process validation, design change, rework of nonconforming product, and CAPA were found to be inadequate. These issues indicate a systemic lack of control over critical quality processes for their Lung Vision System and Tool.