FDA 483 - Carbomedics, Inc - March 29, 2007

An FDA inspection of Carbomedics, Inc., located in Austin, TX, was conducted from March 21 to March 29, 2007. The purpose of this full directed audit was to evaluate the medical device sponsor's adherence to applicable regulations, particularly concerning their adverse event reporting for the clinical investigation of the Mitroflow Pericardial Aortic Valve. The inspection was carried out in accordance with guidelines from CDRH, HFZ-311, and C/P 7348.810, which governs sponsors, contract research organizations, and monitors.

A significant outcome of this nine-day inspection was the determination that no discrepancies or deficiencies were identified. The report explicitly states that no FDA-483, a form used to list objectionable conditions, was issued to Carbomedics, Inc. All aspects of the review, including monitoring procedures, subject records, adverse experience reporting, and device accountability, were found to be in order. While there were discussion items regarding missing adverse event forms for two specific patients, these were promptly addressed by management during the inspection, with the required documentation provided. Consequently, no formal regulatory actions or corrective measures were deemed necessary for Carbomedics, Inc., reflecting a compliant status during this audit.