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This can result in millions of lost investment, sales, and value in your company. The best thing your company can do in preparation for an FDA appoved audit is to hire an outside pharmaceutical consultant to help you correct any errors and correct any paperwork to prepare for your next examination.
Another problem with failed tests is that only the more stringent line tests are performed. Any differences on the second or third examination will be considered more carefully than on the first examination.
You'll also want to review any new data, including revised procedures, and even visit clinical researchers who work for you.
You will want to review and review all company information and data recorded by your clinical investigator and ensure there are no discrepancies in any of the reports. Failure to do a more thorough test can result in more tests, which don't get any easier.