Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers. Problems with CAPA top the list of reasons for 483s and warning letters from the FDA year after year, and many companies struggle to identify when they should even initiate a CAPA.

When companies are uncertain about what should trigger a CAPA, they tend to make one of two mistakes:
• They get “CAPA happy.” In this case, every incident is treated as CAPA-worthy, which leads to mountains of paperwork and enormous stress. As the CAPAs pile up, the backlog slows progress to a crawl, and the company may suffer “death by CAPA.”
• They ignore CAPA-worthy issues. On the other hand, some companies don’t escalate issues to CAPA when action is warranted. This underuse of the CAPA process leaves them vulnerable to 483s and warning letters from FDA, and has an adverse effect on the safety and efficacy of their devices.

 …