Warning Letters and Untitled Letters
Warning Letters and Untitled Letters
Warning Letters and Untitled Letters
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Format• Common Elements– Title: “WARNING LETTER”– Addressed to highest known official in the firm• If <strong>Warning</strong> Letter concerns inspectional findings, acopy is sent to highest known official at facility– Dates of inspection; a description of violativeproduct, practice, or process; <strong>and</strong> citation tolaw or regulation violated– Dem<strong>and</strong> that corrective action be taken, <strong>and</strong>that a written response be provided within 15days6
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