Even though your company may prepare sufficiently for FDA audit review, there's still a possibility your company might not pass the exam. So what then? What exactly happens if your entire pre-inspection prep is for nothing, and you neglected your review anyhow?
It does not exactly mean you'll get surrendered in prison or have your business cleaned off the books anytime shortly, but it might lead to serious problems for your business in the case of an inspection collapse. There are many companies like Wizmed who provide you the best services of professionals for FDA inspection 483.
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Below are a few impacts your company may face if you neglect your FDA Inspection.
One serious result of this is that the information will likely spread, which might harm your reputation for a corporation. This might create a loss of customer confidence, your inventory prices might well return, along your business partners and investors can eliminate faith in your business. This may lead to millions of lost investments, earnings, and value within your business.
As we all know what is an FDA inspection? So, the very best thing your organization can do when preparing for an FDA review would be to employ an external pharmaceutical consultancy company that may help you to fix any errors you may have needed and to correct all of the paperwork appropriately to prepare your next review.
Another issue with failing a review is it will only result in more stringent inspections down the road. Any discrepancies you might have during the third or second time around will be more closely scrutinized than they might have been through the initial review.
Another concern of neglecting a lot of inspections is the chance your organization could be brought upon fraud. In case your program has been denied again and again, and you are neglecting every review, the FDA has inside legal right to sue you for an attempt at fraud.
Then they can invoke the Software Coding Policy, which will carefully inspect every portion of the organization's dealings including its internal audits, clinical records, and also in which the money is moving. Your organization could then be pressured using incorrect acts, or fraud suits and your company may be shut permanently.