The Silent Treatment and Other Classic FDAer Tricks

The Silent Treatment and Other Classic FDAer Tricks

March 8th, 2013 // 7:03 pm @

March 19, 2013

We hear a lot about tricks that FDA auditors like to use to get information out of companies. One of the most common is when they give you ‘the silent treatment’ during the inspection or at the conference table.

The idea is for them to be quiet and wait for you to fill the empty air with words. Often times, we will just keep talking because we are nervous and having silence makes us more nervous. So we keep talking. And as we keep talking, we reveal things about our quality systems or our complaint handling that we may not have.

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This is why when you have an FDA inspection, remember that you should not say more than is necessary. Answer the question, and then be quiet.You should wait for them to ask for what systems they want to inspect at your pharmaceutical company. Do not volunteer anything.

Remember that anything you say can be used against the firm and you.

‘The silent treatment’ is definitely an FDA auditor classic trick. There are four others that they love to use as well. Find out more about them in our April 11 Webinar, How to Survive an FDA Inspection.

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