FDA 483 - Prism Clinical Imaging Inc. - September 19, 2019

An FDA inspection of Prism Clinical Imaging Inc. in Elm Grove, WI, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for software installation, design changes, finished device acceptance, and complaint handling. These issues indicate a systemic lack of adherence to internal procedures and regulatory requirements, particularly concerning software development and post-market activities.