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FDA Enforces Consent Decree Over J&J/McNeil's OTC Manufacturing

This article was originally published in The Tan Sheet

Executive Summary

FDA will wield tight oversight of Johnson & Johnson subsidiary McNeil Consumer Healthcare's OTC manufacturing operations under a consent decree filed after the firm's quality-control changes failed to satisfy the agency.

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In a frank warning at a FDLI meeting, DoJ Director of Consumer Protection Michael Blume says the agency’s role is clear once it takes on a case investigated by FDA or FTC. Blume notes the dietary supplement category “has become something of an emphasis for us in the department.”

DoJ Aims To ‘Do Something About’ Crime In FDA-Regulated Industries

In a frank warning at a FDLI meeting, DoJ Director of Consumer Protection Michael Blume says the agency’s role is clear once it takes on a case investigated by FDA or FTC. Blume notes the dietary supplement category “has become something of an emphasis for us in the department.”

DoJ Aims To ‘Do Something About’ Crime In FDA-Regulated Industries

In a frank warning at a recent FDLI conference, DoJ Director of Consumer Protection Michael Blume says the agency’s role is clear once it takes on a case investigated by FDA or FTC. “We are committed to prosecuting individuals, and we’re seeing that now, more and more,” Blume said.

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