How to Prepare for an FDA Inspection

T

tallu

Hi,

Simple question: How to prepare for an FDA inspection?

1. Tips and hints are welcome.

2. And if you can keep it short - tell your stories of your companies FDA inspection.

2a. It can be the one where everything went wrong - I don't lose my night dreams after reading horror stories.
2b. Or it can be the happy one - inspector didn't find any lacks.
We are starting to prepare to face our FDA inspection in the end of the summer - So all posts are welcome!

ps. Our company design and manufactures Class II medical devices. Two of our devices got FDA approval.
 
L

lfrost

This happened last Friday, and I am sure was an isolated incident.

At 11:45 am an FDA Inspector approached our receptionist and stated that he was here to "Inspect your facillity." Our receptionist did what she was supposed to do and notified our management representative, who is our general manager. He requested from the FDA Inspector to see his credentials, which he was shown. Then he asked the inspector why we were not notified previously of the inspection. He was told that the reason why he was there was not for a facillity inspection, but to verify our registration which hadn't been paid.

Our GM said, "I believe that I did that in October." The inspector replied that his manager's database stated that we were not registered. The GM said, "Let's go in my office and look on the FURLS website." Which they did and he showed the inspector that the company was registered and that the fees had been paid on October 2, 2012.

The GM then asked, "Would you like a copy of this?" To which the inspector said, "No, that won't be necessary. I just don't understand why my manager's database is so far out of date."

The GM replied, "Well, maybe you should write yourself a 'nonconformance' then." To which the inspector said nothing but excused himself from our building.

The GM told me in the afternoon, that if and when we are inspected again, (we were inspected four years ago) that if we receive any observations on a 483 that it will probably be because of his flippant remark. :lol: :lol:

I know that this was probably something that you were not really wanting, but I thought that you would want to know that the FDA is not infalable.

I would say that the best way to prepare for an FDA Inspection is to read and become familiar with the QSIT manual.
 
M

MIREGMGR

I would say that the best way to prepare for an FDA Inspection is to read and become familiar with the QSIT manual.

I think this is second best.

I think having ISO 13485 and CE certifications issued by a tough NB is the best preparation, since those certifications typically cause annual third party audits. Nothing is as good preparation for a rigorous outside audit process as prior rigorous outside audits.

Practice makes perfect.
 
M

MIREGMGR

Note by the way that companies can be excused from US FDA QSIT 1/2 audit exposure (a year at a time) by qualifying under the Voluntary Audit Report Submission Program. If you're already subject to ISO 13485 and you have a rigorous NB (as recognized by FDA), and your past two years' ISO 13485 audits have been clean, that's the easiest way of all to "prepare" for FDA audit.
 

GStough

Leader
Super Moderator
I think this is second best.

I think having ISO 13485 and CE certifications issued by a tough NB is the best preparation, since those certifications typically cause annual third party audits. Nothing is as good preparation for a rigorous outside audit process as prior rigorous outside audits.

Practice makes perfect.

Absolutely agree with MIREGMGR. :agree1::agree::yes:

However, if this isn't the case, it is still possible to come through an FDA inspection with no 483s issued. When I worked at a company (for 13 years) that didn't hold these certifications, my main responsibility was to know :read: the requirements of the QSR and 21 CFR 820 and make sure that we complied with all those requirements, where they were applicable to our business.

Proper documentation and file management were very important in ensuring compliance so that no nonconformances were found. We were able to prove that we operated in a state of control and the FDA Inspector was satisfied.

If your company doesn't have the certifications mentioned above, don't worry, you can still come through your FDA inspection without any issues. Best of luck to you! :agree1:
 

AnaMariaVR2

Trusted Information Resource
does your company has an SOP for FDA inspections?
If not, create one & train/evaluate your staff. Get prepared.

good luck!
:cfingers:
 

rvanelli

Involved In Discussions
If you're already subject to ISO 13485 and you have a rigorous NB (as recognized by FDA), and your past two years' ISO 13485 audits have been clean, that's the easiest way of all to "prepare" for FDA audit.

How can you determine if your NB is "rigorous...as recognized by the FDA"?

You are referring to the accreditation board and not the registrar, correct?
 
M

MIREGMGR

How can you determine if your NB is "rigorous... as recognized by the FDA"?

The provided quote was in reference to the FDA Voluntary Audit Report Submission Program. Per its Guidance, FDA nominally accepts participants who have been audited against ISO 13485 and certified by a Notified Body or other auditing party under the regulatory systems of the EU, Australia, Japan or Canada. This of course would seem to include most NBs conducting ISO 13485 audits.

My understanding, though, is that FDA considers the general reputation of, and their and possibly outside contacts' other knowledge of the work of, the NB or other auditor identified on a VARSP application and stated on the provided ISO 13485 certificates in determining whether to accept the VARSP application.

It's well known that a few NBs are less rigorous than the norm. My understanding is that FDA is aware of that fact and takes it into account.

My comment that you quoted was a reference to the fact that audit experience with a rigorous NB would be good preparation for an FDA inspection.

In direct response to your question: I think most experienced regulatory personnel working in an ISO 13485 context are aware of whether their NB is "rigorous", based on past audit processes and other interactions.
 
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