Venus Concept Inc – FDA 483, Jan 16, 2020

Venus Concept Inc, a medical device manufacturer in San Jose, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately document and timely process corrective and preventive actions (CAPAs), with a majority of reviewed CAPAs showing issues. Additionally, complaint files were not properly maintained, exhibiting problems with timely reporting, thorough investigation, and accurate malfunction evaluations.