It’s no secret that Food and Drug Administration (FDA) inspectors hone in on a medical device company’s corrective and preventive action (CAPA) program during an inspection. But a leading CAPA consultant says many companies may have overreacted and made things unnecessarily difficult for themselves.

“Audits we’ve worked on often come after the FDA has found CAPA deficiencies [at a company],” says John DiMaria, product market manager at BSI Group America Inc.

Irony No. 1. DiMaria says it’s usually not a problem of a company doing too little. “They take a ‘better safe than sorry’ approach,” where they label almost any anomaly as a problem that triggers their CAPA machinery,” he says. In other words, they are doing too much. “They launch into a 10-step procedure that requires management sign-off” and a whole lot of other time-consuming activities.

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