Question

Please consider the purpose of the CAPA document, consider if there was no corrective action procedure, what would be possible consequences? How would we stand up in an inspection by the FDA?

Answer 1

CAPA : Corrective actions and Preventive actions, are used for identifying, assessing and improving upon the anomalies or defects in a process, or product, or practice.

If theere was no corrective action procedure, the consequences could vary depending upon the nature of the agenda and action items, and their associated gravity in context of the quality of the product/process. They could vary from subtle warnings or notices to strong recommendations, or could be even shutting down of a plant!

I'm case FDA inspects a process where corrective actions are not implemented, there could be serious consequences such as issuing of warnings and breach of quality notices. Repeated offense could lead to a more strict punitive action from FDA such as a statutory shut down of the facility or even legal action.