Hello,

My company is a dental medical device manufacturer and we are registered under 13485. We have entered into our CAPA database, numerous corrective action requests that are related to transportation damage, minor customer complaints and other non-high risk/safety issues. We have another database that handles minor issues, but unfortunately, these were entered into our CAPA database. My question is, can we withdraw this as a Corrective Action but still handle it in another manner.
An FDA agent auditing one of our sister plants with a similar problem, told them they had to "finish it" under the current system. Any thoughts on this?

Doesn't "finsihing it" consist of explaining that the reports in question were entered into the CAPA database due to faulty operations, and then explaining how your correction will be to move them to the correct database and your prevention will be to change your operational procedure and perhaps do some retraining so that the same mistake will not occur again?

That all sounds like desirable CAPA work that you might as well just do.

Thank you. That is what I think also, but I am having difficulty getting my boss to agree with me.

I would just finish the CAR just in case your site gets the same FDA auditor. Since the wrong data base was used, it sounds like there might be an opportunity to clarify the criteria as to which data base to use.