FDA 483 - Clinical Diagnostic Solutions, Inc. - August 02, 2022

Clinical Diagnostic Solutions, Inc. in Plantation, FL, a manufacturer of diagnostic solutions, was inspected from July 21 to August 2, 2022. The inspection revealed severe and systemic deficiencies across multiple quality system areas, many of which are repeat observations from previous FDA inspections in 2012 and 2015. Key issues include inadequate complaint handling, ineffective corrective and preventive actions, poor control of nonconforming product, and incomplete process validation and risk analysis.