FDA 483 - Criticare Technologies, Inc. - October 28, 2025

An FDA inspection of Criticare Technologies, Inc. in Warwick, RI, revealed significant and repeat deficiencies in their quality system for nGenuity and eQuality Vital Signs Monitors. Key issues included inadequate corrective and preventive actions, flawed complaint handling and MDR procedures, insufficient design verification and validation, and a failure to properly assess the impact of out-of-tolerance test equipment. The firm also lacked adequate purchasing controls, documented production processes, and an updated design risk analysis, indicating systemic problems in ensuring device quality and safety.