FDA 483 - Vincent DiGiovanni, DO - August 18, 2025

An FDA Form 483 was issued to Clinical Investigator Vincent DiGiovanni, DO, following an inspection conducted from August 11 to August 18, 2025. The inspection revealed two significant observations regarding the conduct of a clinical investigation, indicating non-compliance with regulatory expectations for clinical trials.

The primary issue identified was the failure to maintain accurate and complete records of each subject's case history. Specifically, the Clinical Investigator did not ensure proper documentation of adverse events and serious adverse events (SAEs), with instances of inaccurate reporting dates and delayed acknowledgment. Issues also included inadequate records demonstrating that appropriately delegated, trained, and qualified personnel conducted subject visits, assessments like the Revised Venous Clinical Severity Score, and other protocol-required study activities, such as adverse event and device deficiency assessments and physical examinations.

The second observation noted that the investigation was not conducted in accordance with the investigational plan. This was evidenced by the untimely transmission of SAE reports to the study sponsor, with significant delays ranging from 90 to 243 days beyond the required timeframe for several subjects. These observations highlight the need for Dr. DiGiovanni to implement corrective actions to ensure all clinical trial records are accurate, complete, and submitted within established timelines, and that all study activities are performed by qualified personnel as per the protocol and regulatory guidelines.