FDA 483 Inspection Observations

If you are a medical device manufacturer and have registered a Class II or III product with the FDA, the FDA will review you.

Whether you have previously had an FDA examination or not, I highly recommend that you take the time to prepare for your next visit. You may get more info about FDA inspection 483 via https://wizmed.com/inspections.

There are several surefire ways to fail the FDA exam and get dozens of FDA 483 observations. And despite your best efforts, you will likely end up with around 483.

Your behavior during the FDA examination is of course important. Even more important, however, is your FDA-compliant behavior after 483 checks and closes.

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When the FDA inspector completes the examination, he will give you a summary of his observations. If the inspector finds a problem, he or she will go over the draft and submit Form 483 of Inspection to the FDA. The inspector will ask if you agreed to fix the problem and write down your answer.

And make sure you understand the observations and comments of the FDA inspectors. Ask questions before the inspectors close Project 483 and leave your facility. A clear understanding of these issues is essential for you so that you can respond to and address FDA concerns.

What you do next is the most important step towards resolution 483. Find out that the clock is ticking and you have 15 days to provide the FDA with an initial response to 483 observations.

Don't wait to get the official FDA verification report! This may not happen 30 days or more after the examination.