I've taken for granted that no one would intentionally want to ignore an FDA Form 483. But just in case you thought about it, you'll want to reconsider. Read this Outsourcing-Pharma post, "Ignore a form 483? Not wise say FDA." Bottomline, doing nothing increases the likelihood of receiving a warning letter. In summary the FDA believes that “a well-reasoned, complete, and timely 483 response is in your best interest”.
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Medical Device Sponsors - FDA Trends and Tips To Avoid 483s
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples
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