FDA 483 - EMED Technologies Corporation - March 17, 2021

During an FDA inspection from March 11-17, 2021, EMED Technologies Corporation, a medical device manufacturer in El Dorado Hills, CA, was cited for inadequate complaint handling procedures. The firm's procedures failed to properly define requirements for evaluating complaints to determine if they were reportable to the FDA, a critical lapse demonstrated by numerous unassessed complaint records involving device malfunctions. This indicates a significant deficiency in their quality system regarding post-market surveillance and regulatory reporting.