Nonconformance & CAPA

If there's one area of your quality management system that FDA inspectors scrutinize most closely, it's your CAPA program. Year after year, corrective and preventive action remains one of the top citations on FDA Form 483 observations and warning letters. And yet, most organizations treat CAPA like a checkbox exercise rather than the problem-solving system it's supposed to be. The result? Recurring nonconformances, repeat findings during inspections, and warning letters that