FDA 483 - CAIRE DIAGNOSTICS INC - August 03, 2021

CAIRE DIAGNOSTICS INC in Pleasanton, CA, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately investigate customer complaints, maintain device history records, and establish proper corrective and preventive action procedures. Additionally, procedures for identifying product during various stages were not established, leading to commingling of rejected and accepted raw materials.