Determine suspect vs illegitimate product status and required actions including quarantine, investigation, and 72-hour FDA Form 3911 notification. Terminal stage of pharma-serialization-custody chain.
DSCSA §582(h)Zero PIIClient-side onlyUS FDA · 72-Hour Form 3911
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Scope
Assesses a product flagged after saleable-returns refusal or autonomous alert against DSCSA suspect/illegitimate criteria. Emits required_actions: quarantine, investigate, and/or FDA_FORM_3911_72H (illegitimate only). Terminal stage of the pharma-serialization-custody chain.