FDA 483 - CooperVision Lens Care Limited - November 15, 2018

CooperVision Lens Care Limited in Ashford, Kent, United Kingdom, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies in environmental controls, process validation for water sampling, implementation of validated test methods, corrective and preventive action procedures, and the statistical rationale for sampling methods. These issues indicate a lack of adequate control over critical manufacturing processes and quality systems.