FDA 483 - Leventon S. A. U. - March 22, 2018

Leventon S. A. U., a device manufacturer in Sant Esteve Sesrovires, Spain, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, lacked validation for critical manufacturing processes, and did not submit required Medical Device Reports (MDRs) for device malfunctions. Additionally, issues were noted with design change procedures, process controls, and acceptance criteria for in-process product.