Failing an FDA Inspection

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Failing an FDA Inspection

 Although your company may prepare itself sufficiently, even going over and above the necessary steps in preparing for your FDA audit inspection, there is still a chance that your company may not pass the test.  So what then?  So what happens if all your pre-inspection preparation is all for nothing, and you failed your inspection anyway?  Well it doesn’t exactly mean that you’ll get thrown in jail, or have your company wiped off the books anytime soon, but it may cause serious problems to your company in the event of an inspection failure.  Here are some consequences your company might face if you fail your FDA Inspection.
 
One severe consequence of this is that the news will very likely become public, which could damage your reputation as a company.  This may result in a loss of consumer confidence, your stock prices could very well go down, and your business partners and investors may lose faith in your company.  This could result in millions of lost investment, sales, and value in your company.  The best thing your company can do when preparing for an FDA inspection is to hire an outside pharmaceutical consultancy firm that can help you fix any mistakes you might have had, and to fix all the paper work accordingly to prepare for your next inspection.
 
Another problem with failing an inspection is that it will only lead to more rigorous inspections down the line.  Any discrepancies you may have during the second or third time around will be much more closely scrutinized than it would have been during the first inspection.  They will also want to verify any new data you may have, including any revised procedures, and may even visit the clinical investigators working for you.  They will want to check, and double check all the company information and data registered by your clinical investigators very closely, and make sure there is no discrepancy in either report.  Failing an even more scrutinized inspection can further lead to more inspections, which won’t get any easier.
 
One problem you might face in the wake of more and more failed inspections is the possibility of being disbarred.  This means that the FDA can debar you from having any activity in the company, or any company, with a pending or approved NDA or ANDA.  This could not only put your individual career on the shelf for quite a period of time, but can hurt your company in further tests down the line.  In fact, before any company with a submitted NDA or ANDA try again in the testing process, they must verify that no debarred individuals took part in the testing, or it will automatically fail.
 
Another concern of failing too many inspections is the possibility that your company could be brought up on fraud.  If your application is being denied time and time again, and you’re failing each and every inspection, the FDA is within legal right to sue you for an attempt at fraud.  They then could invoke the Applications Integrity Policy, which will closely scrutinize every part of the company’s dealings including its own internal audits, clinical records, and where the money is going.  Your company could then be forced with a wrong acts, or fraud lawsuit and your company could be closed down permanently.

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normal">Nigel Smart
Nigel Smart is a pharmaceutical consultant and founder of the pharmaceutical consulting blog.