FDA 483 - Q'apel Medical, Inc. - March 08, 2022

Q'apel Medical, Inc. in Fremont, CA, a manufacturer of medical devices, was cited for significant deficiencies in its quality system. The firm failed to submit Medical Device Reports (MDRs) for serious malfunctions of its Walrus Balloon Guide Catheter System and did not adequately implement its Corrective and Preventive Action (CAPA) procedure for complaint trending. These issues indicate a failure to properly address and report device-related adverse events.