Blog
January 22, 2026
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 […]
January 21, 2026
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. […]
January 20, 2026
A complaint legally requires CAPA when it signals loss of control in the quality system—not when it hits a numeric or procedural threshold.From an FDA enforcement […]
January 19, 2026
CAPA Survival Playbooks — Kandih Bioscience If your CAPA depends on complaints—but your complaint handling system is weak—your CAPA is already dead.From an FDA inspection perspective, […]
