FDA 483 - Maternova, Inc. - June 12, 2024

An FDA inspection of Maternova, Inc., an importer of medical devices in Providence, RI, revealed significant deficiencies in the firm's complaint handling procedures. The company failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, and a specific complaint record lacked essential details and a reportability determination. These findings indicate a serious lapse in quality system requirements related to complaint management.