Failing an FDA inspection is not the end of the world, but it can sure bring on a lot of trouble for you and your company. Either because of recklessness or because you did not prepare enough for the inspectors’ visit. Failure at this stage will make the FDA doubt if your method of analysis and the way you plan to manufacture your product are as you claim, “the best”. If after reviewing the submitted information and establishing detailed specifications for manufacture and control of your product, FDA inspectors still won’t let you pass, then trouble is just around the corner, and a lot of issues need to be solved.
Some pharmaceutical consulting firms have identified the most common problems to be expected after failing FDA inspections. Here is a list:
INCREASED NUMBER OF INSPECTIONS: Discrepancies will lead to re-inspections to verify new data, repeated testing, and revised procedures. Inspectors will check that you made the suitable changes and will probably visit different clinical investigators working with you as well. They need to compare that all information submitted in the application matches the one obtained in your company and the data registered by the clinical investigators.
THE APPLICATIONS INTEGRITY POLICY: Severe inconsistencies can be interpreted as an attempt of fraud. Simple errors in the recording of data will make information become utterly unreliable for the FDA. Then, they may invoke the Applications Integrity Policy, forcing the company to conduct its own internal audits, to check all the discrepancies between the submitted data and the real information. The company will also be forced to identify for the FDA all individuals involved in the so-called “wrongful acts” and remove them from any leading position in matters under FDA jurisdiction.
DEBARMENT: Any person held materially responsible for data discrepancies or inconsistencies at an FDA inspection can be debarred. This means that he may not provide his professional services to any company with a pending or approved NDA or ANDA. In fact, any company submitting an NDA or ANDA to the FDA must first certify that no debarred individuals participated in their application process.
CRIMINAL INVESTIGATION: The Department’s criminal investigative powers are the most significant consequence of not passing the inspection. Once the FDA starts thinking that there may be some fraud associated with your NDA submission, your exposure to criminal prosecution as a company or individual increases dramatically. Apart from being terribly disruptive to the company, it has a negative impact on your workers’ morale.
DELAY IN APPROVAL FOR PRODUCTS NOT YET MARKETED: If the FDA considers your facility at fault, they will not approve any pending NDAs. The argument is simple: faulty cGMPs.
IMPACT ON ONGOING RESEARCH: As in the case of clinical research under IND exemption, and especially when manufacture or clinical testing has been performed in the same facility of the pending NDA.
As information from 483’s is published regularly, there is no way to prevent your failure from becoming public. This will affect your reputation, and bring on some market issues as well: consumers’ trust in your product will be lost, and stock prices will be affected negatively. All in all, failing an FDA inspection is a big disaster that you want to avoid by all means. Your pharmaceutical consultants don’t exaggerate the paperwork and records you need to prepare. They talk from experience, and if you don’t follow their advice on doing things right from the beginning, at least be wise enough to have them around when you need to get out of trouble.
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