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DEVICE CIVIL PENALTY PROCESSING DELAYS GIVE FIRMS TIME TO MAKE CORRECTIONS, FDA TELLS REP. BARTON; LEXICOR GETS WAIVER DUE IN PART TO CORRECTIVE ACTIONS

This article was originally published in The Gray Sheet

Executive Summary

Device civil penalty processing delays by FDA can benefit companies by giving them time to take corrective actions that could deflect final imposition of the fines, FDA says in a recent letter to Rep. Joe Barton (R-Tex.) responding to the House Commerce/Oversight Subcommittee chairman's inquiry into the agency's civil money penalties program.

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