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-- Dealing with a "Difficult" FDA Investigator --

What is a "difficult" FDA Investigator? I used the word "difficult", but remember what may seem "difficult" by one company may be perceived as entirely reasonable by another. To one company an FDA Investigator who asking a lot of questions, could be seen as being "DIFFICULT". But, in fact, that is exactly what an FDA investigator is supposed to do.

The job of an FDA investigator, as I was taught when I went through FDA training school, was to be the EYES and EARS of the agency. Reporting and documenting all the facts necessary to allow the agency to take appropriate action.

The investigator is supposed to asked questions and depending on the situation, the investigator will ask as many questions as is necessary to gain a good understanding of the company, its products, and how well the company is complying with the regulations.

In a perfect world where investigators are trained the same way and do the same type of inspections you would think you would have uniformity in how the investigations are handled. THIS IS NOT A PERFECT WORLD. The main thing to remember is that investigators are people and people vary. This goes for the manner in which different investigators conduct their investigations.

It has always been an industry problem that in some parts of the country the type and time of FDA inspections are much more extensive than in other parts - making some companies feel that they are being unfairly treated. The FDA is trying it best to try to get their investigators to conduct the inspections in the most uniform manner. The FDA’s new QSIT (quality system inspection technique) inspectional format is the closest the FDA has come to trying to get the investigators thinking and conducting their inspections in the same manner. Whether it will work remains to be seen. From the discussions I have had with various investigators, the QSIT inspectional format is not particularly comfortable to them. Falling off the wagon and going back to their old ways may be too hard to resist.

So what constitutes a "difficult" FDA investigator?

I would say that any investigator that treats you with disrespect could qualify as a "difficult" investigator. An investigator has no right to treat you in a way that embarrasses or degrades you. A good investigator would even keep his cool if you started to treat him/her with a lack of respect. The investigators are supposed to be trained to handle adverse working conditions including management that are not friendly to the agency.
Investigators are trained not use harsh words (especially four letter words).
Investigators are not supposed to force their way into areas or files that they are told not to go. The FDA has other recourse to get these records, i.e. court orders.
Investigators are not supposed to hit you (though I never heard of an investigator doing this).

If you were involved in any of the above listed situations with an investigator, I would conclude that you are dealing with a difficult investigator and immediately contact their supervisor or the District Director and ask for the investigator to be removed and replaced with another investigator. But, make sure that if you are going to ask for the investigator to be removed, you have fully documented your case and have examples of the inappropriate manners you feel are forcing you to make this request.

What about the real "difficult" FDA investigator who asks a lot of questions and no matter what your answer is, it doesn’t seem right enough to satisfy him/her?

Or the FDA investigator who appears to know more about your process than you and starts to imply that you are not doing things the way they should be done, according to him or her?

How about the FDA investigator who seems to "have it in for you" and no matter how good your documentation is, he/she finds fault?

What about the last situation when the investigator doesn’t appear to "know what they are talking about," and during the inspection starts to request information or responses that don’t appear to make any sense to you?

These would all be difficult situations to deal with. You feel that things are getting out of control and that you are in jeopardy of a potential legal problem. It might seem that your only recourse would be to meet with the investigator’s supervisor or go even higher and visit with the District Director. However...the old saying about "those who can keep their cool when all around them lose their head" could be the best way to approach the situation.

Let the inspection take its course. Have someone take detailed notes of what the investigator says, and his/her actions, and your response. These might be very important at a later time if there is some question as to what really occurred.

Once the investigator issues the FDA 483, you should review each point, and if possible address each issue. If there are some observations to be disputed this is the time to point them out. The more documented evidence you have the better your chances of having a point removed. An investigator can remove a point from the 483. Don’t believe them if they say they can’t.

All your corrective actions completed during the inspection should be annotated on the 483.

If there are areas of dispute, where you have not been able to get your point across, it is better to end the discussion, explaining that you disagree and will make your comments in your written reply.

Once the inspection ends you now have to address the investigator’s observations. You have to remember that the investigator’s observations are only his/her observations. They are not set in stone and it doesn’t mean that they are correct. It is now up to you to put together a reply that expresses your concern, your reasons why the investigator’s observation may not have affected the safety or efficacy of the product, and why the investigator perhaps did not understand what was being explained to him/her.

You have another option and that is to set up an appointment with the District office to meet with the compliance officer to discuss the 483 and the investigator’s attitude. You have to be prepared to present evidence of your compliance and, in a professional manner, address your concerns as to the investigator's ability to understand the operations.

For the most part, the FDA investigators are not out to get you. They are people and as such will always be greatly diversified in their abilities and temperament. Be prepared to deal with the situation, get the necessary documentation and though it may be hard at times to hold your temper, try your best to stay professional. Your time will come to express your concerns.

Next Month’s Insight Report –

The next Insight Report Vol. 3 #4

A legal look at the ISO 9000

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