Consent Decree Tempers J&J Consumer Outlook Even As Remediation Ends
This article was originally published in The Pink Sheet Daily
Executive Summary
CFO Dominic Caruso says the firm is more consistent with distributing previously recalled OTCs. U.S. OTC sales jumped 10.7% and “steady progress” is anticipated when the firm completes its remediation responsibilities under a consent decree with FDA.
You may also be interested in...
Missing CAPA Costs J&J $25 Million In Investigation Sparked By OTC Recalls
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.
J&J Bit Off More Than McNeil Could Chew In 2006 Pfizer OTC Acquisition
McNeil scaled up its manufacturing “volume and complexity substantially” following J&J’s acquisition of Pfizer’s consumer business in 2006, says McNeil Consumer VP Shane Freedman. “Just a few years later, we had the recalls” that led eventually to a consent decree with FDA,” he says.
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela Diesch suggested at the Independent Beauty Association’s Cosmetics Convergence Spring Symposium. Attendees also sought her take on whether the agency’s new recall authority is likely to spell an increase in cosmetic product recalls.