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Missing CAPA Costs J&J $25 Million In Investigation Sparked By OTC Recalls

This article was originally published in The Tan Sheet

Executive Summary

J&J/McNeil enter a guilty plea in federal court to a misdemeanor charge of distributing adulterated drugs and agree to pay a criminal fine of $20 million and forfeit $5 million. McNeil has submitted to FDA experts’ certifications of remediation processes being complete at its three facilities subject to a consent decree.


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