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Yes—FDA expects complaint trending before CAPA initiation.From an inspection perspective, complaint trending is a diagnostic function, not an effectiveness check. If trending only occurs after CAPA […]

CAPA Survival Playbooks — Kandih Bioscience Repeat FDA 483 observations almost always mean the original root cause was wrong.From an FDA enforcement perspective, recurrence equals misdiagnosis. […]

CAPA Survival Playbooks — Kandih Bioscience CAPA does not sit in QA.From an FDA inspection perspective, CAPA sits at the intersection of complaints, design controls, supplier/CMO […]

CAPA Survival Playbooks — Kandih Bioscience CAPAs Don’t Fail at Closure—They Fail at the Source Most CAPA programs don’t fail because teams can’t write corrective actions.They […]