FDA 483 - LimFlow, Inc. - May 15, 2023

LIMFLOW INC, a sponsor in San Jose, CA, was cited for significant deficiencies during an inspection related to an investigational study. The firm failed to ensure proper monitoring, promptly inform the FDA of significant new information, and accurately report adverse events and device deficiencies. Additionally, an investigator was found to be non-compliant with the investigational plan, and the firm did not promptly secure their compliance.