FDA Urges Device Manufacturers To Double-Check Their CAPA Systems

From the June 2007 issue of "The Silver Sheet"

Corrective and preventive action (CAPA) violations were cited in 87% of device warning letters last year, leading FDA to remind firms to fully investigate complaints, find the root cause of nonconforming products and document their CAPA activities.

According to statistics compiled by FDA, 69 out of 79 quality system warning letters sent to firms in calendar year 2006 included at least one CAPA observation.

"I can tell you that from reviewing inspection reports and writing up warning letters, pretty much everything that comes across my desk [includes] some sort of CAPA observation, " Melissa Torres, a biomedical engineer in CDRH's Office of Compliance, said at a recent Association for the Advancement of Medical Instrumentation (AAMI) seminar in Arlington, Va.

"CAPA is a really, really important thing that we look at, and ... we do see a lot of companies having issues with it."

FDA's 2006 statistics are consistent with the previous three years, when CAPA violations were cited at roughly the same rates.

"CAPA is a whole entire system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause" of nonconformities, Torres said. "CAPA is not just a simple, little issue. It's more of a process and a culture, and has to be understood throughout your organization."

In particular, FDA has found that many firms fail to properly document CAPA activities. That mistake was cited on 29% of FDA-483 inspection forms in 2006.

FDA GMP/Quality Systems Expert Kim Trautman said many companies don't follow their own CAPA documentation procedures, while others do not perform any CAPA documentation at all. She reminds firms that if their CAPA activities are not documented, then FDA "really never knows if it's done."

- Shawn M. Schmitt

More on CAPA and FDA's recommendations for compliance appears in the June issue of "The Silver Sheet."

CLICK HERE to sign up for a free trial of "The Silver Sheet."