FDA 483 - Advanced Monitored Caregiving, Inc. - January 31, 2025

Advanced Monitored Caregiving, Inc. in New York, a software manufacturer, received a Form FDA 483 for significant deficiencies in its quality system. The inspection revealed issues with the design history file for its CareConsole software platform, including a lack of design plans, formal reviews, and proper verification and validation activities. Additionally, the firm failed to provide justification for not reporting a device correction to the FDA and demonstrated inadequate complaint handling procedures, particularly concerning Medical Device Reporting assessments.