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Timely 483 Response Can Ease Agency Enforcement Action – FDA Official

This article was originally published in The Tan Sheet

Executive Summary

A substantive and timely response to a form 483 can help a firm avoid or mitigate further FDA enforcement action, a senior agency official says.

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Form 483 Reply Can Be Ticket To FDA’s Good Side – Attorney

Taking a conciliatory tone and showing a commitment to compliance can help a company avoid further enforcement action after receiving a form 483 from FDA that details “significant” inspectional observations, says food and drug attorney Kate Beardsley.

Form 483 Reply Can Be Ticket To FDA’s Good Side – Attorney

Taking a conciliatory tone and showing a commitment to compliance can help a company avoid further enforcement action after receiving a form 483 from FDA that details “significant” inspectional observations, says food and drug attorney Kate Beardsley.

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