What to do Before and After an FDA Inspection

Aphel

Involved In Discussions
#1
Hello,

Few days ago my company got a notice that we will have a FDA inspection in three months...

It will be our first inspection... :mg:
And it will be a "one man 5-day routine inspection"...

Do you have any advices for me regarding preparation activities...?
We already informed us especially about how an inspector conducts during the five days, and we have special SOP for FDA inspections...

But what should we do before the inspection starts:

Contact the FDA to get some detailed information about the person who will come?
Should we try to find out what kind of inspection it will be - level 1,2,3 and so on...?
Should we try to find out somthing about potential inspected products?


And then... what are the right attitudes after the inspection:


What should we do after a VAI?
What should we do after an OAI?
How should we respond to an EIR or a Warning Letter?


Sorry for that many questions... but we want to be prepared as good as possible for this "event of the year" in our company.

Thank you very much in advance for your help and your support.

Have a nice weekend,
Aphel
 
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Aphel

Involved In Discussions
#3
Hello Somashekar,

Thanks for your reply... I already know the QSIT guide... unfortunately it does not contain hints regarding behaviors when an FDA insector is in the house, or what to do after getting a warning letter, or an EIR...

I just was asking for experiences, code of conducts an and so on from other companies...

Best regards,
Aphel
 
N

njhoost

#4
Unfortunately every inspector is different.

Are you in the US?

The only reason I ask I the fact that you would get a letter scheduling you three months out. Usually it is a very fast turn-around from them from when they announce their inspection to them actually showing up (at least in the US).

Depending on the country and the product you are manufacturing/shipping and how you are distributing the products, there are literally thousands of scenarios and audit objectives one can go through concerning.

Knowing your country where audit is being held, products you primarily manufacture (Generic is fine but category/class would be helpful) will help get you better support in your questions. Basically what is it that you do and who do sell to (i.e. importers, OEMs who reprocessos etc.) that gives you exposure to the FDA.

Basically they are pushing down into Major medical companies OEM suppliers that may or may not be medical component suppliers, which is why I also ask.

I only ask to help as I am audited/visited by them in the US an every single investigator is as different as the next.

As an overall guide make sure your complaint, recall, capa and adverse event procedures all reference applicable 21 CFR sections and satisfy their requirements accordingly and make sure your MDR signoffs and time frames are documents. As well as having you management rep appointed as well as the individual in charge of approving new documents.

There is more but I am sure other forums have covered this as well at far greater detail than me.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Hello Somashekar,

Thanks for your reply... I already know the QSIT guide... unfortunately it does not contain hints regarding behaviors when an FDA insector is in the house, or what to do after getting a warning letter, or an EIR...

I just was asking for experiences, code of conducts an and so on from other companies...

Best regards,
Aphel
Just to answer a small part of your questions -

"What to do after getting a warning Letter" is very simple - just address everything in the letter. They tell you exactly what they expect in your response, and within what timeframes. All you have to do is read and cooperate.

For some reason which I can't get, too many companies (not referring to yours by any means) are trying to play smart with the FDA, only to find out later that (a) the FDA is "smarter", (b) problems don't tend to go away if you ignore them, and (c) they are still in the exact same spot, only a bit older and less sympathized by the FDA.

I truly hope you won't have to deal with any warning letters. Checking upfront whether you are compliant is a step in the right direction.

:cfingers:

Ronen.
 

Aphel

Involved In Discussions
#6
Hello,

I left out some relevant information for you:

The company I am working for is a medical device manufacturer, the products are in class 1 and class 2, some with 510k, some without 510k...

The company is located in Europe and we sell products to the US market via daughter-distribution companies in the US... these distribution companies are located in the US and belong to us.

Hope this gives you a clear picture of my situation.

Can you tell me - does it make sense - after receiving their letter with the notice of inspection - to contact the FDA to find out some details about the inspector who will come, what products are in focus and so on?

Another question - is necessary to have a lawyer with us, when the inspection takes place?

Thanks a lot, best regards,
Aphel
 

Ajit Basrur

Staff member
Admin
#8
...
Can you tell me - does it make sense - after receiving their letter with the notice of inspection - to contact the FDA to find out some details about the inspector who will come, what products are in focus and so on?

Another question - is necessary to have a lawyer with us, when the inspection takes place?

Thanks a lot, best regards,
Aphel
My thoughts -

In fact, the FDA will inform you the name of the inspector in the ispection notice. I am not sure if they do this only for overseas inspection or for all inpsetcions ? In all of the overseas inspections that I have been involved had the inspector name.

On getting a lawyer, my 2 cents is No. Why would you require ? The inspector is coming to inspect your systems and you are the best person to explain to them.

All inspections should be held in an open and trustworthy atmosphere. :)
 
T

treesei

#9
Aphel,

I am not trying to advise you. This is only something from my experience in the past.

But what should we do before the inspection starts:

Contact the FDA to get some detailed information about the person who will come?
Should we try to find out what kind of inspection it will be - level 1,2,3 and so on...?
Should we try to find out somthing about potential inspected products?




And then... what are the right attitudes after the inspection:


Aphel
We did not make any contact with FDA. The inspection was a routine one. We make sure all documents are available. We set of a support team in a "war room" to make sure anything FDA wants to see (if reasonable and usually it is) is ready in minutes. We focused on higher risk and more current products/records. In our first inspection, they spent a lot of time on CAPA and software validation.

Afterwards, prepare corrective/preventive actions on issues found during inspection. Work hard, fast, and in depth. Try not to play games with FDA and be straight. You need to clarify things with FDA but do not try the marketing kind bullxxxt.

Need a lawyer during inspection? Probably not. Inspectors are not ready to deal with lawyers during inspection and it is not a good time to have lawyer-style negotiation. This may only slow things down and irritate the inspector. But have your regulatory people there.

Have someone sit in the inspection room full-time to record the activities and communicate with the support team.

Good luck. Once you have gone thru the inspection you will find it not as horrible as you imagine, if you have been doing your duties.
 

Wes Bucey

Quite Involved in Discussions
#10
My knowledge is of US-based inspections only. Inspector(s) will be very detailed in confirming all required documentation for the operation and the product is available.

The primary red flag which makes FDA inspectors drool is observing activity which does not exactly follow the plan outlined in the organization's "Current Good Manufacturing Practices" process documentation.

I have several giant FDA-regulated organizations in my geographic region and many of my ASQ Section members work in them. Anecdotally, those folks stress never try to 'jawbone' the inspector into believing you "always" or "never" do something, but do show evidence you have a documented routine to audit your processes to assure any glitches are caught and corrected.
 
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