FMD 2018 Level I Training Book

3/23/18

Warning Letters — A warning letter may be used where there is a  suspected  violation that is amenable to correction within 90 days or less. — It is not a decision or determination that violations have in fact occurred, which would require administrative process to be afforded to the facility prior to such a decision or determination being made. — Warning Letters should not be used for: — Serious Violations that would trigger the issuance of a Notice of Violation. — Where it is anticipated that corrective action will take longer than 90 days.

Preliminary Notice of Violation — A PNOV is appropriate where an audit or investigation has revealed a violation. — A PNOV should identify: — The facts alleged — What corrective actions are required — The consequences for failure to take the specified corrective action

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