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