FDA 483 - CAREstream Medical Ltd - April 27, 2022

CAREstream Medical Ltd, a medical device manufacturer in Lake Mary, FL, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, particularly concerning complaint handling, purchasing controls, design controls, design history file maintenance, and risk analysis for their platelet and plasma separator device. These issues indicate a lack of established and maintained procedures critical for ensuring device safety and effectiveness.