FDA 483 Listing Observations - Mostly Corrective Action and Root Causes?

[sreenu927]

Hi All..
Most of the 483 listing observations include " CAPA procedures are not adequately established" and/or "Complaint handling procedures are not adequately established with no designated unit".

In such cases, usually what could be the root cause, other than the lack of understanding or misinterpretation of regulatory requirements?

I am just thinking further down and down and understood (may be wrong!!) that the potential root cause could be "misinterpretation of requirements".

The other observations like, "acceptance activities are not documented" and "Unapproved documents/editable docs were found to be use in ..". In these cases, the root cause is "lack of training on the use of documents or completing documents".

Any thoughts?

Regards,
Sreenu

 

[Stijloor]

A Quick Bump!

Can someone help Sreenu?

Thank you very much!!

 

[TWA - not the airline]

You could still dig deeper: Why do people responsible for authoring prodecures lack the necessary regulatory knowledge? Inadequate training procedures? Ressource issues escaping management's awareness?
Or: Why do inadequate procedures get approved? Doc control issue, procedure does not call for QA/RA review approval? Such practices should be found by internal audits, so why did they not? So again a management review issue?

The thing is, that in the end it is the responsibility of management to ensure that the QMS is working, so if it is a systematic problem the real root cause is always management (unfortunately typically only external auditors can tell that to their face). If it is a single event it could be anything; however for single events you may only need to correct the problem and not perform a full root cause analysis to get down to the systematic error (and for preventive action start with management...)

 

[MIREGMGR]

My understanding is that in most audits where those findings are included, the inspector determines that the company either doesn't have a real quality system at all, or has only the minimum system that they think might be enough to fend off FDA...in both cases, usually because the owner or management think that regulation is a waste of time and money and an imposition on their freedom to do whatever they want.

 

[mr.mike]

MIREGMGR, maybe this is the case for some, but I'd like to think stating this is the case for "most" such findings would be overly cynical....

As our FDA inspector explained, when issuing a 483, for each observation the inspector must select from a pre-defined list of observation headings. As such, relatively minor (or as the original poster mentions, misinterpretations/misunderstandings) may be listed under headings which may (unfortunately) give the impression of gross gaps in the system.

For example from ours:

"Procedures for management review have not been adequately established."
...but the actual observation was only that we were just listing attendees, and not getting actual signatures (proof) of attendance.

I have a feeling that most 483s with observations like "procedures for X have not been adequately established" are in fact misinterpretations/misunderstandings of FDA expectations, rather than gross, deliberate negligence.

...but maybe I'm just overly optimistic...

 

[Java23]

I found a document - not sure how to enter an attachment here but, here is the address to the article:

http://www.fda.gov/ICECI/EnforcementActions/ucm250729.htm#A_Short_Description_of_Citations

Have not read the entire document but, it may be helpful.