FDA 483 - Criticare Technologies, Inc. - May 10, 2024

Criticare Technologies, Inc. in Warwick, RI, received a Form FDA 483 with 10 observations following an inspection from March to May 2024. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, complaint handling, risk analysis, and design controls. These issues indicate a systemic breakdown in ensuring the quality and safety of their vital signs monitors, with several observations being repeats from previous inspections.