FDA EIR - Carbomedics, Inc - March 29, 2007

An FDA inspection of Carbomedics, Inc., a medical device sponsor located in Austin, Texas, was conducted from March 21 to March 29, 2007. The audit, carried out under the guidance of CDRH and specific compliance directives (C/P 7348.810), aimed to assess the firm's adherence to applicable regulations, particularly regarding the clinical investigation of its Mitroflow Pericardial Aortic Valve, and its process for reporting adverse events to the FDA. The inspection encompassed a review of the company's clinical research oversight, monitoring procedures, subject records, adverse event reporting, and device accountability related to its ongoing clinical trials. Notably, the firm manufactures the Mitroflow valve in Vancouver, Canada, which is approved for export and use in Canada, with ongoing U.S. and international clinical investigations. During the seven-day audit, the FDA investigator found no discrepancies or violations. Consequently, no FDA-483, which lists inspectional observations, was issued to Carbomedics, Inc. While two minor discussion points arose concerning missing adverse event forms for specific patients, these were promptly addressed and rectified by the company during the inspection. Therefore, no formal corrective actions were required by the FDA following this inspection.