Cambridge Diagnostic Products, Inc. – FDA 483, Mar 16, 2023

Cambridge Diagnostic Products, Inc. in Ft Lauderdale, FL, a medical device manufacturer, was inspected and received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in their quality system, including inadequate complaint handling, medical device reporting, equipment calibration, contractor evaluation, and internal quality audit procedures. These issues indicate a systemic lack of adherence to quality system regulations.