FDA 483 - CAREstream Medical Ltd - February 06, 2026

CAREstream Medical Ltd, a medical device manufacturer in Lake Mary, FL, was cited for multiple deficiencies in its quality management system during an FDA inspection. The observations highlight inadequate documentation for QMS, design and development, and complaint handling, alongside failures in management review, software validation, UDI labeling, and supplier evaluation. These issues indicate significant non-compliance with regulatory requirements for medical device manufacturing.