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Issues: Whether the demand was barred by limitation and the extended period under section 11A could be invoked.
Analysis: The product had been cleared after filing a classification list that was approved, along with the relevant label and drug-control documentation. The Department had all material facts necessary to examine classification, and the record did not establish deliberate suppression or misdeclaration so as to justify the extended limitation period. On these facts, the notice could not rest on the proviso to section 11A.
Conclusion: The demand was time-barred and the extended period of limitation was not invocable.