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