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.