FDA

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FDA Warning Letter citations showing CAPA failure patterns across medical device companies

Why CAPA Systems Rot (And Why Naming Names Does Not Fix It)

A deep dive into conflict avoidance as the root cause of FDA quality system failures. Analysis of 500 enforcement actions shows that CAPA failures are not procedural problems. They are cognitive problems that require a different objective function.

John Sambrook · July 20, 2026 #medical-devices #fda #capa #theory-of-constraints #quality

FDA enforcement data showing seven recurring failure patterns across medical device companies

The Same Seven Mistakes, Every Company, Every Decade

What 500 FDA enforcement actions reveal about how organizations think. The same seven failure patterns appear across medical device companies, decade after decade. The root cause is not poor procedures. It is cognitive biases that evolved for small-group survival but break down in modern industrial settings.

John Sambrook · July 20, 2026 #medical-devices #fda #theory-of-constraints #quality #cognitive-bias

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